BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE SIDE GRASPER FORCEPS

    MDR report key: 1655135 · Received April 7, 2010

    Report

    Report Number
    1418479-2010-00005
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    February 22, 2010
    Report Date
    April 7, 2010
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    BWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    JAW BROKEN. EVALUATION SUMMARY: VISUAL INSPECTION OF THE FORCEPS WITH BROKEN JAW SHOWED NO CORROSION AT THE POINT OF BREAKAGE. THE FORCEPS IS APPROXIMATELY 6 YEARS OLD. THE INSULATION IS IN GOOD CONDITION. OUR REPAIR RECORDS SHOW THAT THIS FACILITY PURCHASED A MORE THAN ONE OF THESE FORCEPS OF THIS LOT NUMBER 1U03 IN 2004. WE CONSIDER THIS AN ISOLATED OCCURRENCE SINCE NO OTHER COMPLAINTS OF THIS TYPE ARE IN THE SYSTEM. CAUSE OF EVENT: NORMAL WEAR AND TEAR FOR THIS PERIOD OF TIME IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE GRASPER DURING A LAPAROSCOPIC SIGMOID RESECTION, THE JAW BROKE OFF INSIDE THE PATIENT. THE PIECE WAS RETRIEVED AND ACCOUNTED FOR BY THE SURGEON AND THE OR STAFF. THE JAW PIECE WAS DISCARDED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVE SIDE GRASPER FORCEPS WAVE SIDE GRASPER FORCEPS BWB RICHARD WOLF MEDICAL INSTRUMENTS 8383.2937 1U03

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR