BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CUSHING GANGLION HOOK

    MDR report key: 2943673 · Received January 30, 2013

    Report

    Report Number
    2943673
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 30, 2013
    Manufacturer
    SYMMETRY SURGICAL A DIV OF SYMMETRY MEDICAL
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE NERVE HOOK DURING THE PROCEDURE. WHEN THE SURGEON PASSED THE NERVE HOOK BACK TO THE SCRUB NURSE, THE NURSE IMMEDIATELY NOTED THAT THE TIP OF THE NERVE HOOK WAS MISSING. THE NURSE IMMEDIATELY NOTIFIED THE SURGEON. THE SURGEON RETRIEVED THE TIP OF THE NERVE HOOK AND PASSED IT TO THE SCRUB NURSE. SCRUB NURSE THEN PASSED BOTH PIECES OF THE NERVE HOOK OFF THE STERILE FIELD. ALL PARTS OF THE NERVE HOOK WERE ACCOUNTED FOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?POSTERIOR LUMBAR MICRODISECTOMY RIGHT LUMBAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41467 CODMAN CUSHING GANGLION HOOK HOOK, SURGICAL GDG SYMMETRY SURGICAL A DIV OF SYMMETRY MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER THERAPIES