Forceps/Irrigation Plug

Olympus' investigation into reported infection and contamination complaints associated with the MAJ-891 revealed a potential risk of patient infection due to inadvertent retention of biomaterial when the reprocessing procedure for the MAJ-891 is not performed as instructed, such as not  disconnecting the MAJ-891 from the endoscope and disassembling it before reprocessing.
In the period of August 1, 2021 to May 1, 2024, Olympus identified one-hundred and twenty (120) serious injuries and one (1) death reported due to infection following procedures in which the MAJ-891 was used with a cystoscope (CYF scope). Investigation by Olympus indicates that there was improper reprocessing in most of these infection cases. Olympus has not received any infection-related complaints for cases where the MAJ-891 was used with other compatible endoscopes including ureteroscopes (URF series), choledochoscopes (CHF series), hysteroscopes (HYF series), and ventriculoscopes (VEF series), although it should be noted that the risk of infection as a result of improper reprocessing is also applicable to these endoscopes.
Due to the risk of infection that may result from improper MAJ-891 reprocessing, alternatives to the MAJ-891 should be used instead. A list of Olympus alternative irrigation plugs that can be used with certain Olympus scopes is listed in the supplied medical device recall letter.
If no alternative for the MAJ-891 is available, Olympus is reminding customers to closely follow the reprocessing instructions as indicated in the instructions for use.
Olympus is also reminding users to inspect the biopsy valve (MAJ-579), used as illustrated in the letter in the MAJ-891 for damage or deformation and replace the biopsy valve if damage is identified. A damaged or deformed biopsy valve may impact the efficacy of reprocessing.

Recall start date: December 20, 2024