BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVE SIDE GRASPER FORCEPS

    MDR report key: 786632 · Received November 21, 2006

    Report

    Report Number
    1418479-2006-00026
    Event Type
    Injury
    Date Received
    November 21, 2006
    Date of Event
    October 27, 2006
    Report Date
    November 21, 2006
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 8393.2937-WAVE SIDE GRASPER FORCEPS. THE WAVE SIDE GRASPER IS A SINGLE PIECE DESIGN WITH DOUBLE ACTION JAW AND RATCHET HANDLE WITH HF POST. THE JAW IS MANUFACTURED AT ENDOPLUS, INC. THE ASSEMBLY OF THE WAVE SIDE GRASPER IS DONE AT ENDOPLUS, INC. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION PERFORMS THE LASER MARKING ONLY. VISUAL INSPECTION CONFIRMED THAT THE JAW IS ATRAUMATICALLY ROUND INSIDE AND OUTSIDE. THERE WERE NO SHARP EDGES VISUALLY AND TO THE MANUAL TOUCH. THE INSULATION HAD RECEDED 1 MM FROM THE DISTAL TIP. THE IRRIGATION CONNECTOR WAS CHIPPED. IT IS OUR OBSERVATION THAT THE FORCEPS REQUIRE ROUTINE MAINTENANCE TO REPLACE INSULATION AND THE IRRIGATION CONNECTOR, NEITHER OF WHICH IS A FACTOR IN THE INCIDENT. A VISUAL INSPECTION AND EVALUATION WAS DONE AT RICHARD WOLF MEDICAL INSTRUMENTS DUE TO THE REQUIRED REPAIR MAINTENANCE ON THE GRASPER. THERE WERE TWO OTHER GRASPERS OF THE SAME TYPE RETURNED FOR INSPECTION ONLY AND NOT ASSOCIATED WITH THIS INCIDENT. BOTH GRASPERS WERE UN-REPAIRABLE AND NON-WOLF PARTS USED WHEN REPAIRED. INSULATION WAS DAMAGED AND PARTS MISSING. BOTH GRASPERS WERE RETURNED TO THE FACILITY. CAUSE OF EVENT: NO CONCLUSION CAN BE DRAWN. THERE WERE NO FINDINGS THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE THE GRASPER WAS BEING USED TO HOLD THE APPENDIX. THE APPENDIX TORE FREE FROM THE BOWEL AND THE PROCEDURE WAS CONVERTED TO OPEN SO THAT REPAIR COULD BE DONE. IT WAS REPORTED THAT THE DOCTOR FEELS THAT THE GRASPER WAS NOT FUNCTIONING PROPERLY AND THAT IT TRANSECTED THE APPENDIX. THE DOCTOR TRIED TWO OTHER GRASPERS BEFORE USING THE ONE HE DID USE DURING THIS INCIDENT. THE TIPS ON THE OTHER TWO DID NOT LINE UP CORRECTLY. IT WAS REPORTED THE LEVEL OF IMPACT: TEMPORARY HARM, MAJOR TREATMENT. TEMPORARY OR REVERSIBLE EFFECT ON PATIENT REQUIRING HIGHER LEVEL OF CARE SUCH AS INITIAL OR PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVE SIDE GRASPER FORCEPS WAVE SIDE GRASPER FORCEPS GCJ RICHARD WOLF MEDICAL INSTRUMENTS 8393.2937 1U04

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention