Dive Brief:
- The Food and Drug Administration on Friday confirmed a Class 1 recall of an Olympus reusable endoscope accessory tied to 120 injuries and one death, about six weeks after alerting the public that the company told healthcare providers to stop using the device.
- The December early alert, part of a pilot effort to inform the public sooner about potential device problems, came five days after Olympus notified customers that improper reprocessing of the part, called a forceps/irrigation plug model MAJ-891, could lead to infection. Olympus recommended in its Dec. 18 notice that providers use alternative devices when available.
- In recent years, Olympus has recalled other devices because of patient safety risks and received three FDA warning letters related to its endoscopes.
Dive Insight:
Safety concerns associated with the reprocessing of endoscopes have driven a shift to single-use options, but reusable endoscopes are still widely used.
Olympus discontinued the MAJ-891 in the U.S. in 2022, but customers may still be using it, the company said in a Jan. 29 press release. The reusable device attaches to the instrument channel port of certain Olympus endoscopes to enable irrigation and use of endotherapy accessories.
In its Class I recall notice, the agency’s most serious classification, the FDA said patient exposure to a contaminated MAJ-891 device could result in injuries such as infection, sepsis or death.
Olympus notified customers of the contamination risk after a thorough assessment of adverse event complaints involving the patient injuries and death, company spokesperson Jennifer Bannan said in an email to MedTech Dive.
When the reprocessing procedure is not performed as instructed, including completely removing and disassembling the device, there is potential for inadvertent retention of biomaterial, the FDA said in a recall database entry. The recall covers more than 30,000 devices distributed across the U.S.
Olympus recommends customers use alternative devices available for its cystoscopes and ureteroscopes. However, there are no alternative Olympus irrigation plugs for use with choledochoscopes and hysteroscopes.
In those situations, customers should use an alternative endoscope or a non-Olympus irrigation plug that the manufacturer has validated for use with the Olympus endoscope, the company said.
If no alternative for the MAJ-891 is available, customers should closely follow the reprocessing instructions for both the endoscopes and the forceps/irrigation plug, the company said. Olympus emphasized the importance of detaching the accessory from the instrument channel port of the endoscope and disassembling it before it is cleaned, disinfected or sterilized.
In late 2023, Olympus recalled bronchoscopes due to the potential for device combustion and recalled abdominal insufflation devices after reports of malfunctions. The FDA issued a warning letter to the company in March 2023 after an inspection found quality failings in endoscope production, following previous warning letters that raised safety concerns about endoscope reprocessing.
