BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC GRASPER

    MDR report key: 3788349 · Received April 28, 2014

    Report

    Report Number
    MW5035873
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 25, 2014
    Manufacturer
    R WOLF MEDICAL INSTRUMENT CORP
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE LAPAROSCOPIC GRASPER BROKE OFF INSIDE THE ABDOMINAL CAVITY DURING A LAPAROSCOPIC SIGMOID COLECTOMY. ADD'L PHYSICIANS CALLED INTO THE OPERATING ROOM. X-RAYS TAKEN. INCISION MADE TO RETRIEVE THE FOREIGN BODY. REASON FOR USE: USED DURING LAPAROSCOPIC SIGMOID COLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253534 ENDOSCOPIC GRASPER ENDOSCOPIC GRASPER KOG R WOLF MEDICAL INSTRUMENT CORP 8393-2936

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other