BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR FORCEPS, WORKING LENGTH 125MM, TIP 1.5

    MDR report key: 1640956 · Received February 5, 2010

    Report

    Report Number
    8010177-2009-00235
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    GEI
    PMA / PMN Number
    K896450
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 7/1/2006 TO 7/1/2008, WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION #(B)(4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE (GXI).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. PT WAS UNDERGOING A SUPRAORBITAL KEYHOLE CRANIOTOMY. THE ELECTROSURGICAL BIPOLAR FORCEPS WERE REQUESTED BUT WERE DETERMINED TO BE NON-FUNCTIONING. SURGEON DECIDED TO TERMINATE THE PROCEDURE. CLOSED THE PT AND WAS SENT TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR FORCEPS, WORKING LENGTH 125MM, TIP 1.5 INSTRUMENT GEI STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other