The US Food and Drug Administration (FDA) has issued an alert relating to a problem with a component on endoscopes manufactured by Olympus that may be “high-risk.”
Olympus sent affected customers an Urgent Medical Device Advisory Notice letter on 18 December, with the FDA alert coming on the 23 December, as part of a communications pilot to enhance medical device recalls.
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The issue relates to patient infections when the MAJ-891 forceps/irrigation plug, an accessory on certain endoscopes, has improper or incomplete reprocessing. Endoscope reprocessing is the process of cleaning and disinfecting reusable endoscopes to reduce the risk of infection and ensure patient safety.
Not disconnecting the MAJ-891 from the endoscope or properly disassembling it before it is cleaned, disinfected, or sterilised can result in patient injury. Injuries include infection, urinary tract infection, sepsis, and, in some cases, death.
Olympus has reported 120 injuries and one report of death due to infection following procedures where plug was used with a cystoscope, a type of endoscopy device that examines the urinary tract. Olympus stated there is also a risk of infection after improper reprocessing when the MAJ-891 is connected to ureteroscopes, choledochoscopes, hysteroscopes, and ventriculoscopes, though there have been no reported cases.
Olympus did not immediately respond to Medical Device Network for comment.
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By GlobalDataOlympus is the market leader in the cystoscopy device market, according to GlobalData, occupying 26.7% of the global market share. The endoscopic market was estimated to be worth $15.8bn in 2024 with it forecast to grow to $29bn by 2033.
The FDA has not issued a recall yet, saying it is “aware of a potentially high-risk device issue” and that it will “keep the public informed and update [the early alert webpage] as significant new information becomes available.”
Olympus has told customers to use compatible alternatives to the MAJ-891. The company added that if no alternative is available, then users should closely follow reprocessing instructions. The biopsy valve should also be checked for damage or deformation as this can impact reprocessing efficacy.
Olympus’s endoscope line was involved in a recall in December 2023, after reports of fires and burns related to the company’s bronchoscopes. The FDA classed the recall, which spanned more than 17,600 devices, as Class I.
