BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3090499 · Received May 2, 2013

    Report

    Report Number
    3005075853-2013-02110
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? YES. WAS THE SURGEON ABLE TO VISUALIZE A CLIP FED INTO THE JAWS PRIOR TO FIRING THE DEVICE? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? THE DEVICE WAS FIRED OUT OF THE PATIENT AFTER THE INCIDENT. WHAT WERE THE INDICATIONS FOR SURGERY? ASKU. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? YES, ERCP DONE IN (B)(6) 2013 AND STINTED THE COMMON BILE DUCT. THE PATIENT HAD AN ENLARGED CYSTIC DUCT. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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, 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST CLIP FIRED FINE. THE SECOND CLIP ONLY LOADED HALF-WAY INTO THE JAWS. THE DEVICE WAS TAKEN OUT OF THE PATIENT. THE DEVICE WAS FIRED AND THE SECOND CLIP DROPPED OUT OF THE JAWS OF THE DEVICE. THE DEVICE WAS FIRED AGAIN AND THE CLIP DID NOT LOAD. THE DEVICE WAS FIRED AGAIN AND THE THIRD CLIP FINALLY LOADED WITH NO ISSUES. THREE OR FOUR MORE CLIPS WERE USED AFTER THE EVENT AND THEY LOADED AND FIRED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193060 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K9063J

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)