BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR SCISSORS

    MDR report key: 2133221 · Received May 9, 2011

    Report

    Report Number
    2936485-2011-00305
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    November 6, 2009
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT BROKE DURING A ROBOTIC HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR SCISSORS SCISSORS GEI STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK