BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINA GOLD LOOP

    MDR report key: 3177551 · Received June 7, 2013

    Report

    Report Number
    3007699067-2013-00001
    Event Type
    Other
    Date Received
    June 7, 2013
    Manufacturer
    LINA MEDICAL
    Product Code
    KNF
    PMA / PMN Number
    D017968
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT PRODUCT OR PICTURES ARE NOT AVAILABLE. IN THIS CASE, THERE IS NOT POSSIBLE TO DETERMINE DIRECT ROOT CAUSE OF THE FAILURE. POSSIBLE ROOT CAUSE CAN BE, THAT THERE WAS ELECTRICAL SHORT CIRCUIT WHICH WAS CAUSED BY TOUCHING THE WIRE OF LOOP WITH ANOTHER STEEL TOOL, OR EVENTUALLY BY INCORRECT SETTING OF POWER ON GENERATOR (TOO HIGH PARAMETERS OR NOT CORRECT PROGRAM WAS SET ON GENERATOR, NO ACCORDING TO IFU). HOWEVER, THERE ARE ONLY ASSUMPTIONS AND ROOT CAUSE OF THE SHORT CIRCUIT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253979 LINA GOLD LOOP LOOP KNF LINA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1