BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3232037 · Received July 17, 2013

    Report

    Report Number
    3005075853-2013-03596
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 3, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). WERE THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? CLIPS JUST SHOT OUT. WAS THE SURGEON ABLE TO VISUALIZE A CLIP FED INTO THE JAWS PRIOR TO FIRING THE DEVICE? NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNK. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? UNK. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNK. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNK. HOW WAS THE CASE COMPLETED? YES. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? UNK. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? UNK. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? NO. PLEASE PROVIDE THE LOT NUMBER TO THE DEVICE IS AVAILABLE? NOT AT ABLE TO SEE THROUGH RED BIO BAG. WHAT WAS THE DATE OF THE PROCEDURE? DR DOES NOT REMEMBER. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? BARIATRIC PROCEDURE. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ON FIRST FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? DR DOES NOT REMEMBER. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? WAS UNABLE TO ADVANCE WITHOUT COMING OUT THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED TWO CLIPS AS INTENDED AND IT EJECTED NINE CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT DURING AN UNKNOWN CASE, THE STAPLES ARE SHOOTING OUT OF THE STAPLER. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331037 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1