BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM BIPOLAR SHAFT

    MDR report key: 2240902 · Received August 8, 2011

    Report

    Report Number
    2936485-2011-00555
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE UNIT WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM, 33CM BIPOLAR SHAFT ELECTROSURGICAL GEI STRYKER ENDOSCOPY SAN JOSE 0915061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK