BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1744923 · Received July 2, 2010

    Report

    Report Number
    3005075853-2010-03703
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INDICATOR WHEEL FAILURE, ADVANCER BYPASS. DEVICES B, C, F BATCH # G9J86U: MFG DATE: 01/21/2010; EXP DATE: 12/21/2014. DEVICE D G9J810: MFG DATE: 01/21/2010; EXP DATE: 12/21/2014. DEVICES E BATCH # G9J818; MFG DATE: 01/20/2010; EXP DATE: 12/20/2014. THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. DURING THE FIRST TWO FIRING SEQUENCES, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; PEAR SHAPED CLIPS WERE RELEASED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT COMPLETELY VISIBLE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. UPON FIRING OF THE DEVICE, IT FED AND PROPERLY FORMED FIFTEEN CLIPS WITHIN MANUFACTURING SPECIFICATIONS AND THEN, IT LOCKED OUT AS INTENDED. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. UPON FIRING OF THE DEVICE, IT FED AND PROPERLY FORMED FIFTEEN CLIPS WITHIN MANUFACTURING SPECIFICATIONS AND THEN, IT LOCKED OUT AS INTENDED. THE ANALYSIS RESULTS FOUND THAT DEVICE (D) WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. UPON FIRING OF THE DEVICE, IT FED AND PROPERLY FORMED FIFTEEN CLIPS WITHIN MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS VISIBLE AT 10TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THE ANALYSIS RESULTS FOUND THAT DEVICE (E) WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. UPON FIRING OF THE DEVICE, IT FED AND PROPERLY FORMED FIFTEEN CLIPS WITHIN MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS VISIBLE AT 10TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE (F) WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY NON-CONFORMANCE. UPON FIRING OF THE DEVICE, IT FED AND PROPERLY FORMED FIFTEEN CLIPS WITHIN MANUFACTURING SPECIFICATIONS AND THEN, IT LOCKED OUT AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS GIVEN WITHOUT ANY DETAILS OF THE EVENT. NO PATIENT IMPACT REPORTED. IT WILL BE RETURNED. THE CUSTOMER IS RETURNING FIVE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RC18

    Patients

    Seq Age Sex Outcome Treatment
    1