The Olympus Corporation out of Pennsylvania issued an Advisory Notice just over a month ago notifying health care professionals of the potential risks associated with continued use of their re-usable Forceps/Irrigation Plug (Isolated Type) model MAJ-891. The FDA published the announcement on Thursday, January 29th.
The Forceps/Irrigation Plug (Isolated Type) model MAJ-891 by Olympus attaches to an endoscope, allowing health care professionals to take tissue samples or irrigate a tissue area during endoscopy. The MAJ-891 is compatible with Olympus cystoscopes, for examination of the bladder or urethra; hysteroscopes, for examination of the uterus; choledochoscopes, for examination of the bile duct; and ureteroscopes, for examination of the kidneys and ureters. The Olympus Corporation discontinued production of the MAJ-891 in 2022, though many health care professionals continue to use MAJ-891 devices purchased prior to that date with their Olympus endoscopes.
To date, Olympus Corporation has received several accounts of injury linked to the re-usable MAJ-891 endoscopy attachment. For this reason, the company is advising health care professionals to to use an alternative device whenever possible. Olympus offers alternative attachments for both their cystoscopes (CYF series) and ureteroscopes (URF series). Because Olympus does not offer any comparable attachments for their choledochoscopes (CHF series) and hysteroscopes (HYF series), health care professionals are urged to use another brand of endoscope.
In the event that the MAJ-981 must be used, Olympus Corporation emphasizes the absolute necessity of following all published guidelines for the disassembly, cleaning, and sterilization of the attachment. Failure to properly sterilize a re-usable endoscopy attachment will likely cause infection for patients undergoing endoscopy with the instrument.
Anyone with questions or concerns about the Advisory Notice pertaining to the MAJ-981 can contact Olympus by phone at (800) 848-9024 (Option 1) or by email at complaints@olympus.com.
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