BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-SHAPED HOOK SUCTION COAGULATOR, 5MM, 32CM

    MDR report key: 1220336 · Received November 3, 2008

    Report

    Report Number
    2430952-2008-00031
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY ORIGINALLY REPORTED THAT THE INSULATED PARTS OF THE HOOKS WERE BURNING/SPARKING DURING GALL BLADDER OPERATIONS. BOTH INSTRUMENTS ARE NEW. ADDITIONAL INFORMATION: THE MATERIALS MANAGER REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-SHAPED HOOK SUCTION COAGULATOR, 5MM, 32CM JARIT ENDOSCOPIC INSTRUMENTS KNS TONTARRA MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1