BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR ADAPTER FOR US STANDARD CABLE

    MDR report key: 2496401 · Received March 15, 2012

    Report

    Report Number
    8010177-2012-00059
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 23, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    GXD
    PMA / PMN Number
    K896450
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    WHILE USING BIPOLAR FORCEPS, A SPARK OCCURRED IN A JOINT OF THE FORCEPS AND AN ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR ADAPTER FOR US STANDARD CABLE INSTRUMENT GXD STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK