BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3112366 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02320
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? NOT SURE WAS NOT IN CASE. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? NOT SURE WAS NOT IN CASE. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NOT SURE WAS NOT IN CASE. WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? NOT SURE WAS NOT IN CASE. WAS THE SURGEON ABLE TO VISUALIZE A CLIP FED INTO THE JAWS PRIOR TO FIRING THE DEVICE? NOT SURE WAS NOT IN CASE. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NOT SURE WAS NOT IN CASE. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NOT SURE WAS NOT IN CASE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NOT SURE WAS NOT IN CASE. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NOT SURE WAS NOT IN CASE. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NOT SURE WAS NOT IN CASE. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? NOT SURE WAS NOT IN CASE. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NOT SURE WAS NOT IN CASE. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? NOT SURE WAS NOT IN CASE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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, THE LARGE CLIP DID NOT SEEM TO CLOSE TIGHTLY ON THE VESSEL AND THE CLIP WOULD FALL OFF OF THE VESSEL. THE ACCOUNT DID NOT STATE THAT THE CLIP WAS MALFORMED, BUT THAT IT DID NOT SEEM TO CLOSE TIGHTLY ON THE VESSEL. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THIS WAS ALL THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212934 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CD40

    Patients

    Seq Age Sex Outcome Treatment
    1