MAJ-891 endoscope accessory

  • Risk of device contamination that may result from improper reprocessing.
  • Company: Olympus Corporation
  • Medical Devices
  • FDA
  • January 29, 2025

Product details

  • MAJ-891 endoscope accessory

Company announcement

Olympus Corporation issued an advisory notice for the MAJ-891 Forceps/Irrigation Plug due to the risk of device contamination from improper reprocessing.

The advisory recommends using alternative devices for Olympus cystoscopes (CYF series) and ureteroscopes (URF series).

For choledochoscopes (CHF series) and hysteroscopes (HYF series), alternative endoscopes or non-Olympus irrigation plugs are advised if no alternative for the MAJ-891 is available.

One death has been reported.

Risk:

The potential harm of improper reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, which could result in patient injury, specifically, infection.

Impacted states: Nationwide

Products:

- Forceps/Irrigation Plug (Isolated Type) model MAJ-891

Contact

For more information, call 800-848-9024, Option 1 or email complaints@olympus.com.

View the original FDA notice

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