BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2250856 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03829
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 25, 2011
    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): EMPTY. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. 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 REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 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? ---AROUND THE GASTRIC BODY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ---NO INFORMATION. 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. 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? ---NO INFORMATION. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? ---NO INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? ---NO INFORMATION. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? ---NO INFORMATION. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? ---NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LADG, SCISSORING OCCURRED. THE CLIPS WERE FORMED AS EXPECTED AT THE TEST FIRING AND AFTER SEVERAL FIRING BEFORE THIS EVENT. ALSO, CLIPS WERE FORMED PROPERLY AFTER SEVERAL FIRINGS FOLLOWING THIS EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1