BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2882280 · Received December 20, 2012

    Report

    Report Number
    3005075853-2012-05849
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 14, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ---NO INFORMATION. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ---NO INFORMATION. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ---NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ---NO INFORMATION. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---NO INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO INFORMATION. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---NO INFORMATION. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ---NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AN UNKNOWN PROCEDURE, THE CLIP EJECTED. NO CLIP FELL INTO THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1