BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3150006 · Received June 6, 2013

    Report

    Report Number
    3005075853-2013-02837
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CLIPPING ON A STAPLE LINE. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNKNOWN. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNKNOWN. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. DEVICE B ADDITIONAL INFORMATION: BATCH # K90P0Y, EXPIRATION DATE: 02/2018, MANUFACTURING DATE: 03/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, BOTH DEVICES WERE SCISSORING CLIPS. THE SURGEON WAS CLIPPING OVER A STAPLE LINE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249862 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CG59

    Patients

    Seq Age Sex Outcome Treatment
    1