BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2860887 · Received December 6, 2012

    Report

    Report Number
    3005075853-2012-05488
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 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
    GR
    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, RETAINED 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? 3RD. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC RESOURCE. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? 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? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? LAP CHOLECYSTECTOMY. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? NO. IF SO, WHAT? DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO. IF SO, WHOM?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PHYSICIAN USED THE DEVICE IN ORDER TO APPLY CLIPS. THE FIRST TWO CLIPS WERE APPLIED AND WHILE TRYING TO APPLY THE THIRD CLIP THE DEVICE LOCKED UP. A NEW SAME LIKE DEVICE WAS USED TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4C91H

    Patients

    Seq Age Sex Outcome Treatment
    1