BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2864422 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05534
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION REQUESTED: 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? ASKU. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNKNOWN. WAS THERE ANY TORQUE OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT 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 AND FED AND FORMED NINE SCISSORED CLIPS, AND THEN THE REMAINING CLIPS WERE FORMED AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. IN ADDITION AS PER THE INSTRUCTIONS FOR USE "DO NOT EXCESSIVELY TWIST OR TORQUE THE INSTRUMENT JAWS WHEN POSITIONING THE INSTRUMENT ON A VESSEL AND FIRING. EXCESSIVE TWISTING OR TORQUING MAY RESULT IN CLIP MALFORMATION". THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, BOTH DEVICES FIRED SCISSORED CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AV5J

    Patients

    Seq Age Sex Outcome Treatment
    1