BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ (1-800-421-0837)

    MDR report key: 106971 · Received July 18, 1997

    Report

    Report Number
    106971
    Event Type
    Malfunction
    Date Received
    July 18, 1997
    Date of Event
    July 8, 1997
    Report Date
    July 18, 1997
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSOCOPIC CHOLECYSTECTOMY A DULL GRASPER BLADE BROKE OFF IN PT'S ABDOMINAL CAVITY. AFTER ATTEMPTS TO RETRIEVE, THE TINY PIECE OF METAL SLIPPED BEHIND THE LIVER. THE SURGEON OPTED TO LEAVE THE METAL PIECE, WHICH IS THE APPROXIMATE SIZE OF THE CLIPS NORMALLY LEFT IN AFTER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ (1-800-421-0837) DISSECTING REDDICK-OLSEN GRASPING FORCEPS GEN KARL STORZ ENDOSCOPY-AMERICA INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other