BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAM CLAMP RATCHET, 5MM 32CM

    MDR report key: 819560 · Received February 15, 2007

    Report

    Report Number
    2430952-2007-00008
    Event Type
    Malfunction
    Date Received
    February 15, 2007
    Date of Event
    June 20, 2005
    Report Date
    February 12, 2007
    Manufacturer
    KOSCHER & WUERTZ GMBH / CHIRURGISCHE INSTRUMENTE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE DEVICE BROKE OOF INSIDE ENDO POUCH DURING A LAPARASCOPIC CHOLECYSTECTOMY SURGERY. ALL PIECES WERE RETRIEVED FROM ENDO POUCH. THE DEVICE WAS DISCARDED. NO PATIENT INJURY WAS REPORTED. A VOLUNTARY MEDWATCH REPORT 1036027 WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLANGIOGRAM CLAMP RATCHET, 5MM 32CM ENDOSCOPIC INSTRUMENT KOG KOSCHER & WUERTZ GMBH / CHIRURGISCHE INSTRUMENTE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR