BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMCAT CUTTER

    MDR report key: 3111498 · Received May 9, 2013

    Report

    Report Number
    MW5030117
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT SHOULDER ARTHROSCOPY, THE SHAVER BEING USED WAS NOTED TO HAVE METAL SHAVINGS COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202523 TOMCAT CUTTER SHAVER GFF STRYKER ENDOSCOPY 375545000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other