Once again, the US Food and Drug Administration is warning providers about the risks of infections associated with a reusable endoscope accessory from Olympus.
Though discontinued from the market in 2022, the MAJ-891 forceps/irrigation plug, which attaches to various Olympus endoscopes, may still be in use.
During certain procedures, such as cystoscopies, ureteroscopies, choledochoscopies and hysteroscopies, the MAJ-861 allows irrigation and use of endotherapy accessories.
However, if the part is not reprocessed correctly – for example, if it is improperly disconnected and disassembled after use -- then biomaterial could remain on the part and infect another patient resulting in serious adverse effects, including urinary tract infection, sepsis or death.
The FDA reported 120 injuries and one death associated with the issue in a 23 December 2024 safety alert issued as part of the FDA’ new pilot to enhance its recall process.
Olympus advised providers to opt for alternative parts due to the risk of ineffective reprocessing and infection from the MAJ-891. But while there are alternative accessories for cystoscopes and ureteroscopes, there are none for choledochoscopes and hysteroscopes, making the potential consequences more dire.
In these cases, providers need to pay extra attention to the company’s reprocessing instructions for both the endoscope and the MAJ-891, especially when detaching the accessory from the scope and disassembling it before cleaning, disinfection, or sterilization.
Confusing and Unclear
But while confirming the class I status of the MAJ-891 recall and reminding customers that the part is no longer on the market, the FDA’s January safety alert on the accessory could have been clearer and more precise, according to device safety specialist and president of LFM Healthcare Solutions Lawrence Muscarella.
“The FDA’s January alert could have better clarified the differences between a device correction and a device removal, and the differences between a device removal, a device recall, and a discontinued device that might continue to be used,” Muscarella told Medtech Insight. “The FDA’s 2025 alert about the MAJ-891, in my opinion, should have made this all explicitly clear, lest a urology clinic become confused, continue using the MAJ-891, and infect a patient. Exactness is critical here, understanding that FDA reports have linked contamination of the MAJ-891 to infections and patient death.”
Muscarella cited the FDA’s language stating the recall “involves removing certain devices from where they are used or sold.”
This adds to the confusion, in his view, considering the agency goes on to say that, as per class I recalls, the continued use of the device may cause serious injury or death.
“The FDA’s January alert states that the recall involves removing the device, but then the alert suggests that the device can continue to be used under certain circumstances, that is, if no alternative for the MAJ-891 is available. This confuses me, and it can complicate tracking the recalled device,” Muscarella said. “It’s important that users understand precisely what FDA is advising so they can ensure their patients are safe.”
According to the FDA, the recall included 30,140 units, which appears to be the number of devices on the market at the time of the class 1 recall, after the MAJ-891 was discontinued in the US in 2022.
This disconnect only adds to the confusion.
“Was there an FDA notice around 2022 stating that the MAJ-891 was being discontinued, and explaining why? I am unaware of any such disclosure.” Muscarella asked. “The FDA’s January alert, in my opinion, again lacks important clarity about this, which is really the purpose of my research on this topic: to sort out the details of this recall and what is and isn’t safe. As part of my work, I ask a broader question to FDA: How many other class 1 recalled devices are being regulated this way?”
But another question for Muscarella is why the MAJ-891 was discontinued in the first place and why the FDA waited so long — nearly two years — to issue a safety alert publicizing the infection risk associated with ineffective reprocessing of the MAJ-891.
The FDA advised healthcare providers about reports of infection associated with reprocessed urological endoscopes in an April 2021 letter, but that is different, in Muscarella’s opinion, from a safety alert focusing on the MAJ-891 device.
Who’s in Control?
Muscarella further said he is confused by which of the recommendations in the FDA’s January alert are from the FDA and which from the company.
Specifically, he referenced the FDA’s advice for customers when no alternative part is available for choledochoscopes and hysteroscopes. In his view, while that advice seems to be the company’s, it is unclear if it’s also that of the agency.
“The alert seems to leave this point unclear for me,” Muscarella said. “I am confused by what FDA is independently advising.”
Moreover, the FDA states one death, along with the 120 injuries, was associated with the recall, with that death coming from an infection following a cystoscopy in which the affected part was used.
However, Muscarella referred Medtech Insight to three separate FDA reports, two in 2020 and one in 2023, linking three deaths to ineffective reprocessing of the MAJ-891.
“I am confused again and, if my research is correct, ask why the FDA’s update does not reference the other two deaths or the FDA’s April 2021 letter, which itself discusses two death reports linked to the MAJ-891 contaminated with Pseudomonas bacteria. This causes me to wonder whether FDA reviewed its medical device database to confirm the actual number of related deaths.”
A Wider Scope
But this is not the only issue with endoscopes, including those from Olympus.
In the past, the company has recalled other scoping devices and in March 2023 the FDA issued a stern warning letter to Olympus regarding single-use endoscope accessories after an inspection of its Tokyo facility.
In that letter, the FDA cited some 160 complaints the company received describing the distal end cover on the instrument or falling off inside of the patient or “dropping out,” posing serious risk.
Further, the FDA said that despite Olympus identifying the number of complaints as higher than typical, the company failed to act to correct the problems with the urgency and focus required.
And in 2022, Medtech Insight reported on an analysis Muscarella conducted on the FDA’s Manufacturer and User Facility Device Experience, or MAUDE, database between 2014 and 2021.
For that analysis, Muscarella examined more than 10,000 adverse event reports across six endoscope categories: Bronchoscopes, colonoscopes, duodenoscopes, ear-nose-throat (ENT) endoscopes, gastroscopes and urological endoscopes. He used 2014 as a baseline because it was when the FDA first publicly linked a duodenoscope to certain multidrug-resistant infections and death.
Muscarella’s review found that the number of adverse events involving actual or potential endoscope contamination — with or without infection — increased for each of the surveyed endoscope types. The largest increase was seen for gastroscopes, which rose from 13 reports in 2014 to 1,135 in 2021 – an increase of 8,630%.
The number of ENT-related adverse events was smallest but still showed a substantial rise, going from one in 2014 to 55 in 2021.
Though he has not performed a detailed analysis of MAUDE for adverse event reports submitted from January 2022 to December 2024 describing endoscope contamination or endoscope-related infection for the six originally studied endoscope types, Muscarella said some recent unpublished data — not his — suggests somewhat of an improvement.
According to those data, if all FDA reports of endoscope contamination or infection were put into a single barrel and not distinguished by endoscope type, Muscarella said, then the number of FDA reports appears to have leveled off in 2024 compared to 2022 and 2023.
Yet, he remains skeptical about the actual number of endoscope-related infection cases.
“My own detailed analysis for 2022-2024, once performed, might show year-to-year increases, at least for certain endoscope types,” he said, adding he will know more soon once he has completed this work.
However, from the data he has reviewed thus far, Muscarella said it appears accurate that the number of infections per month reported to the FDA concerning contamination linked to duodenoscopes of novel designs has decreased in the past few years compared to 2014 through 2021, for which FDA is to receive credit.
This is likely due, he said, to the industry’s introduction of, and medical facilities transitioning to, novel duodenoscope models featuring a removable, single-use distal endcap designed to facilitate cleaning.
Muscarella also addressed the current move away from ethylene oxide (EtO) to clean scopes and the potential impact on mitigating infection risk.
“My published research found that the adoption of EtO to process the older model duodenoscopes with sealed distal ends — that is switching from disinfection to sterilization — promptly terminated several ‘superbug’ outbreaks, preventing additional infections,” he said.
He added, however, that while the reported number of cases of patient-to-patient disease transmissions has gone down, FDA reports suggest that novel duodenoscopes have not eliminated this risk as disposable endoscopes do.
“Some recent reports link novel duodenoscopes not only to infections, but also to patient death,” Muscarella said, adding an October 2024 FDA report links an outbreak of antibiotic-resistant — Pseudomonas aeruginosa — to infections and death.
A separate 2024 FDA report linked another novel duodenoscope model, the distal endcaps of which were referenced by FDA in the March 2023 Olympus warning letter, to an outbreak of a multidrug-resistant organism and death. Muscarella added, though, that this FDA letter did not address infections, noting too that FDA device reports can be inaccurate and incomplete.
“While FDA reports of contamination, infection and death involving novel duodenoscopes have decreased significantly in the past few years, many FDA reports, beginning in late 2019 and early 2020 and continuing through last month describe the disposable endcaps of novel duodenoscope models becoming detached and falling off inside the patient, including not only the patient’s GI tract, but also oral cavity, mouth and lungs,” Muscarella said.
A field safety notice from Olympus in December 2023 warned of the consequences posed by the endcap’s detachment, such as risk of mucosal injury, tissue damage, bleeding, perforation or obstruction due to retained distal cover in the GI tract warranting urgent medical intervention. Additionally, a distal cover that detatches in the oral cavity may cause aspiration, airway obstruction or respiratory distress.
Gastroscopes
Muscarella also spoke to the recent state of gastroscopes, which he had the most dramatic increase in adverse events based on his comprehensive scope review.
Since 2021, the FDA r has continued to report multidrug-resistant infections linked to inadequately reprocessed gastroscopes, Muscarella said.
“Recent FDA reports suggest the risk of gastroscope-related infections remains a real, if also under- recognized, concern today,” he said. “For example, the FDA received a report last month stating a US facility’s gastroscope ‘was suspected to be involved in a Salmonella infection to a patient.’”
Despite these reports, the FDA, according to Muscarella, has yet to advise the public or health care providers about the risk of inadequately reprocessed gastroscopes infecting patients with life- threatening multidrug-resistant organisms.
Muscarella said he has had the same concerns regarding the FDA’s handling of urological scopes and questions whether “the FDA and other federal agencies have been placing sufficient attention and scrutiny on the risk of contaminated urological endoscopes infecting patients.”
