BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA LARGE APPLIER

    MDR report key: 3123991 · Received May 22, 2013

    Report

    Report Number
    3005075853-2013-02489
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST, 2ND AND 3RD. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? NO. 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? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ASKU. WHAT WERE THE INDICATIONS FOR SURGERY? POSSIBLE CANCER, PANCREATIC. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? ASKU. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY WITH POSSIBLE WHIPPLE PROCEDURE, APPROXIMATELY THREE CLIPS WERE APPLIED TO THE RETRO-PERITONEAL VESSELS. THE CLIPS WERE SCISSORED. THE MALFORMED CLIPS MAY HAVE CAUSED DAMAGE TO THE VESSEL; THERE WAS A MINIMAL AMOUNT OF BLOOD. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. ONE OF THE CLIPS WAS RETRIEVED FROM THE PATIENT, BUT IT COULD NOT BE CONFIRMED IF THE OTHER TWO CLIPS WERE RETRIEVED. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225781 LIGACLIP*MCA LARGE APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA J4C46M

    Patients

    Seq Age Sex Outcome Treatment
    1