BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINA GOLD LOOP

    MDR report key: 3177552 · Received June 7, 2013

    Report

    Report Number
    3007699067-2013-00002
    Event Type
    Other
    Date Received
    June 7, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    LINA MEDICAL POLSKA
    Product Code
    KNF
    PMA / PMN Number
    D017968
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT PRODUCT WAS NOT AVAILABLE. IN THIS CASE, THERE IS NOT POSSIBLE TO DETERMINE DIRECT ROOT CAUSE OF THE FAILURE. SOME ASSUMPTIONS CAN BE GIVEN AFTER PICTURES INVESTIGATION. POSSIBLE ROOT CAUSE CAN BE, THAT THE LOOP TUBE WAS MECHANICALLY DAMAGED AND THERE COULD BE AN ELECTRICAL SHORT CIRCUIT ON PLACES WHERE INSULATION BURST, WHICH COULD CAUSE LOOP TUBE PIECES TO SPLINTER. HOWEVER, THERE ARE ONLY ASSUMPTIONS AND ROOT CAUSE OF THE FAILURE CAN NOT BE DETERMINED (THERE IS NO INFORMATION ABOUT THE CONDITION OF PACKAGING COMPONENTS ALSO). THERE IS 100 PERCENT PRODUCT CONTROL DURING ASSEMBLING AND SUCH DEFECTIVE PRODUCTS COULD NOT BE RELEASED FROM FACTORY. DAMAGES COULD BE CAUSED BY EXTREME IMPROPER HANDLING DURING TRANSPORTATION OR AT THE USERS SITE (FORCE NEEDED TO BRAKE THE TUBE IS HIGHLY ABOVE THOSE USED DURING STANDARD SURGERY).

    Description of Event or Problem · 1

    INSULATION ON SHAFT BURNT. CAUSING FRAGMENTS TO SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253723 LINA GOLD LOOP LOOP KNF LINA MEDICAL POLSKA EL-200-8 12142

    Patients

    Seq Age Sex Outcome Treatment
    1