Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus from FDA

The FDA is aware that Olympus has issued a letter to affected health care providers recommending the forceps/irrigation plug accessory to certain endoscopes be removed from use related to a potentially high-risk device issue with the MAJ-891 Forceps/Irrigation Plug (Isolated Type).

Patient infection as a result of exposure to a contaminated device can occur when reprocessing of the MAJ-891 Forceps/Irrigation Plug is improper and/or incomplete, such as not disconnecting the MAJ-891 from the endoscope and disassembling it before reprocessing. This exposure could result in patient injury including infection, urinary tract infection, or sepsis, and, in some cases, could result in death. These harms may require inpatient hospitalization/monitoring, and treatment with oral or intravenous antibiotics.

Olympus has reported 120 injuries and 1 report of death due to infection following procedures in which the MAJ-891 was used with a cystoscope (CYF scope).

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