BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

    MDR report key: 12280616 · Received August 5, 2021

    Report

    Report Number
    8010047-2021-09832
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Report Date
    September 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K912120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN ADDITION, THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE SUBJECT LOT WAS UNKNOWN. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC PRESUMED THAT THE DEVICE HAD BEEN REPROCESSED WITHOUT DISASSEMBLY BY MISTAKE. THE BROWN FOREIGN MATERIAL MIGHT BE FOUND AFTER STERILIZATION DUE TO INSUFFICIENT REPROCESSING OR HANDLING.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE LEVER PART OF MAJ-891 WAS NOT DISASSEMBLED AND WAS IMPROPERLY REPROCESSED. IT WAS ADDITIONALLY REPORTED THAT MAJ-891 WAS DISASSEMBLED INTO TWO PARTS FOR REPROCESSING AT THE USER FACILITY. AFTER AUTOCLAVE STERILIZATION AT 135 DEGREES FOR 8 MINUTES, A BROWN FOREIGN MATERIAL CAME OUT. IT TURNED OUT THAT STERRAD STERILIZATION WAS PERFORMED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE EVENT DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178706 FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG FGB OLYMPUS MEDICAL SYSTEMS CORP. MAJ-891

    Patients

    Seq Age Sex Outcome Treatment
    1