BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA LOOP

    MDR report key: 1935514 · Received December 16, 2010

    Report

    Report Number
    3007699067-2010-00007
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    December 15, 2010
    Manufacturer
    LINA MEDICAL POLSKA SP. Z.O.O
    Product Code
    KNF
    PMA / PMN Number
    K070351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE INVESTIGATION WAS CONDUCTED TO IDENTIFY POSSIBLE CAUSES OF LOOP BREAKAGE AND TARGET APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS. ELECTRON MICROSCOPE PHOTOGRAPHS WERE TAKEN DURING THE INVESTIGATION. CORRECTIVE ACTIONS WERE IMPLEMENTED FOR THE POTENTIAL CAUSES WE WERE ABLE TO DUPLICATE IN THE LABORATORY OR IDENTIFY AS A HIGHLY LIKELY CAUSE. WE ALSO ADDRESSED POTENTIAL CAUSES THAT WERE UNLIKELY TO HAVE CAUSED BREAKAGE IN ORDER TO ADD AN ADD'L MARGIN OF SAFETY. THE LOCATION OF BREAKAGE AND ELECTRON MICROSCOPE EXAMINATION OF THE BROKEN WIRES ARE INDICATIVE OF THE LOOP BEING SUBJECTED TO PRE-TESTING OR COAGULATING CURRENT. IT HAS BEEN REPORTED BY OTHER USERS THAT THEY PRE-TESTS THE LOOP TO DETERMINE IF IT WAS ACTIVE PRIOR TO USING IT FOR THE INTENDED PURPOSE. INSTRUCTIONS FOR USE SPECIFY BLEND ONE SETTINGS TO BE AMPUTATE THE UTERINE BODY. THE SURGEON REPORTED HE DID NOT PRE-TEST AND NO COAGULATING CURRENT WAS USED IN EITHER OF THE PROCEDURES IN WHICH THE DEVICES WERE BROKEN. THEREFORE, THE ROOT CAUSE OF THE BROKEN WIRES IN THESE CASES REMAINS UNK. THE CORRECTIVE/PREVENTIVE ACTION IMPLEMENTED TO ADDRESS THE ISSUE WAS TO ADD THE FOLLOWING STATEMENT TO THE INSTRUCTIONS FOR USE - THE LINA LOOP MUST NOT BE PRE-TESTED UP AGAINST BODILY TISSUE AS TO ASSURE EFFECTIVENESS PRIOR TO ANY CUTTING PROCESS. FIFTEEN POSSIBLE CAUSES WERE TESTED. IMPROPER USE - FAILURE TO FOLLOW INSTRUCTIONS FOR USE WAS DETERMINED TO BE THE MOST LIKELY CAUSE. SIMULATED USE - INADVERTENTLY TOUCHING ANOTHER METAL SURGICAL INSTRUMENT WITH AN ACTIVE LOOP TESTED POSITIVE FOR BREAKAGE. DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    SURGEON REPORTS FOUR LOOPS BROKEN WHEN ACTIVATED. TWO WERE DISCARDED AND TWO WERE RETURNED FOR ANALYSIS. OF THE TWO LINA LOOPS RETURNED, ONE LOOP BROKE WHEN CURRENT WAS APPLIED. THE SECOND LOOP BROKE AS SOON AS CURRENT WAS TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINA LOOP MONOPOLER ENDOSCOPIC LOOP KNF LINA MEDICAL POLSKA SP. Z.O.O EL-160-8 08412

    Patients

    Seq Age Sex Outcome Treatment
    1