BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010099-2007-00001

    MDR report key: 974905 · Received February 2, 2007

    Report

    Report Number
    8010099-2007-00001
    Event Type
    Other
    Date Received
    February 2, 2007
    Product Code
    GAD
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON VISUAL INSPECTION, A SEVERE DEFORMATION OF THE INSTRUMENT WAS NOTICED. THE LATERAL ARMS AS WELL AS THE THUMB LATCH WERE FOUND TO BE DEFORMED. WE COULD NOT FIND ANY DISCOLORATION OR SIGNS OF NORMAL TEAR AND WEAR, WHICH ARE EXPECTED TO BE FOUND AFTER HAVING THE INSTRUMENT USED. NO DEFINITE CONCLUSION FOR THE EXACT CAUSE CAN BE DRAWN. BASED ON OUR LONG-TERM EXPERIENCE AS A QUALIFIED MFR FOR SURGICAL INSTRUMENTS, WE ASSUME, THAT OVERSTRESSING THE INSTRUMENT PROBABLY CAUSED THE DEFORMATION. THIS OVERSTRESSING IS UNLIKELY TO BE RELATED TO THE PROPER USAGE OF INSTRUMENT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAD

    Patients

    Seq Age Sex Outcome Treatment
    1