BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2211840 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03304
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 29, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER BYPASS THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. THE REMAINING FIVE CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS NOT VISIBLE. PLEASE NOTE THE INDICATOR WHEEL CONDITION IS NOT RELATED TO THE REPORTED EVENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING NINE CONSECUTIVE FIRING SEQUENCES CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; PEAR SHAPED CLIPS WERE RELEASED. THE REMAINING THREE CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS OVER-TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, THE CLIPS WOULD NOT ADVANCE. DURING THE PROCEDURE, ONLY THREE CLIPS WERE DELIVERED BY THE CLIP APPLIER. THE SURGEON HEARD AN UNEXPECTED NOISE WHEN HE PRESSED THE HANDLE AND NO MORE CLIPS WERE DELIVERED BY THE DEVICE. NO TORQUING OR TWISTING OF THE DEVICE PRESENTED AT THE TIME OF FIRING. THE DEVICE WAS USED ON SMALL ARTERIOLES. THE DEVICE WAS FIRED AFTER THE INCIDENT OUT OF THE PATIENT BUT THE SAME ISSUE OCCURRED. THE SURGEON USED A SECOND DEVICE WHICH DELIVERED ONLY TWO CLIPS AND THE SAME ISSUE OCCURRED. USING OF A THIRD CLIP APPLIER TO PERFORM THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U35P

    Patients

    Seq Age Sex Outcome Treatment
    1