BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE SIDE GRASPER FORCEPS

    MDR report key: 1888660 · Received October 28, 2010

    Report

    Report Number
    1418479-2010-00019
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 28, 2010
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    BWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OTHER SERVICE ORGANIZATION HAS REPAIRED THIS DEVICE. EVALUATION SUMMARY: VISUAL INSPECTION OF THE FORCEPS WITH BROKEN JAW SHOWED NO CORROSION AT THE POINT OF BREAKAGE. THE BROKEN JAW WAS RETURNED WITH THE FORCEPS. THERE WAS NO EVIDENCE OF CORROSION ON THE JAW. THE FORCEPS ARE APPROXIMATELY (B)(6). THERE IS A DATE ETCHED ON THE HANDLE 1/10 R THAT INDICATES A REPAIR BY A REPAIR SERVICE OTHER THAN RICHARD WOLF MEDICAL INSTRUMENTS. OUR SERVICE RECORDS FOR THIS FACILITY DID NOT SHOW ANY REPAIRS DONE WITH THIS LOT NUMBER 1A07. FOLLOW-UP WITH THE FACILITY CONTACT PERSON DID INDICATE THAT SOMETIMES THE SURGEON WILL TORQUE THE FORCEPS. THE MANUFACTURER WILL BE INVESTIGATING THE FORCEPS AND A FOLLOW-UP WILL BE DONE SHOULD NEW DEVELOPMENTS OCCUR. CAUSE OF EVENT: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE A SMALL HOLE WAS MADE IN THE TRANSVERSE MESOCOLON JUST TO THE LEFT OF LIGAMENT OF TREITZ. THE SMALL BOWEL WAS THEN DELIVERED THROUGH THIS AND UP INTO THE LESSER SAC. AT THIS POINT, THE PROXIMAL GASTRIC POUCH WAS GRASPED AND ELEVATED. A SMALL GASTROTOMY WAS MADE IN THE LATERAL PORTION OF THE STOMACH. A STAPLER WAS CHOSEN AND UTILIZED AT THIS TIME. THE ANVIL AND TROCAR WERE PLACED INTO THE ABDOMEN. THIS WAS PLACED THROUGH THE OPENING IN THE STOMACH POUCH AND EXITED FROM THE MID PORTION OF THE POUCH. THIS WAS CLOSED USING A STAPLER. WHILE TRYING TO REMOVE THE TROCAR OR THE ANVIL, THE GRASPER INSTRUMENT HAD ONE OF ITS SIDES FRACTURE. THE PIECE WAS REMOVED INTACT. THERE WAS NO INJURY TO THE PATIENT. THERE DID NOT APPEAR TO BE ANY RETAINED PIECES. THE REMOVED PIECE DID FIT NICELY IN WITH THE INSTRUMENT WHERE IT BROKE OFF.

    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 1A07

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR