BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS, WAVESIDE GRASPER

    MDR report key: 3112072 · Received May 2, 2013

    Report

    Report Number
    1418479-2013-00015
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 8, 2013
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF (B)(4) 2013. FACILITY WAS CONTACTED TO REQUEST LOT NUMBER AND PHOTO OF DEVICE. LOT NUMBER WAS UNAVAILABLE AND NO PHOTOS WERE TAKEN/SUBMITTED. HANDLE IS MANUFACTURED BY RICHARD WOLF. IT IS THEN SENT TO ENDOPLUS WHERE THEY MANUFACTURE AND ATTACH THE INSULATED SHEATH AND FORCEPS. COMPLETED DEVICE RETURNED TO RICHARD WOLF FOR DISTRIBUTION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, IE, INTENDED USE, INDICATIONS AND FIELD USE, PREPARATION AND CAUTIONS. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM. AFTER USING A SMOOTH GRASPER, IT WAS NOTICED THAT THE INSULATION COVERING THE INSTRUMENT WAS FRAGMENTED NEAR THE HUB. DOCTOR WAS NOTIFIED AND INSTRUMENT WAS REMOVED FROM FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193447 FORCEPS, WAVESIDE GRASPER FORCEPS GEN RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8383-2937

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other