BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ

    MDR report key: 77480 · Received March 17, 1997

    Report

    Report Number
    77480
    Event Type
    Injury
    Date Received
    March 17, 1997
    Date of Event
    February 28, 1997
    Report Date
    March 8, 1997
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN MAJOR SURGERY FOR A LAPAROSCOPIC CHOLECYSTECTOMY. SURGEIN USING SPATULA TO SEPARATE GALL BLADDER FROM THE LIVER BED. THE END OF THE SPATULA SNAPPED OFF AND WENT INTO THE BODY CAVITY. FLUROSCOPY WAS USED TO LOCATE AND RETRIEVE BROKEN PIECE. INSPECTION DONE, NO OTHER PIECES MISSING. APPROX 30-45 MINUTES OF EXTRA SURGERY AND ANESTHESIA TIME. THE MFR WAS NOTIFIED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ ENDOSCOPIC SPATULA GAF KARL STORZ ENDOSCOPY 30873B *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention