BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3214049 · Received July 9, 2013

    Report

    Report Number
    3005075853-2013-03462
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 28, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ATTEMPT WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? UNKNOWN. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? UNKNOWN. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNKNOWN. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? ASKU. IF SO, WHEN? UNKNOWN. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? UNKNOWN. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? UNKNOWN. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? UNKNOWN. 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 AND FED AND FORMED THIRTEEN SCISSORED CLIPS, AND THEN THE REMAINING CLIPS WERE FORMED AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCRUB TECH STATES THAT THE CLIPS WERE "CRISS CROSSED". THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313699 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CU3Z

    Patients

    Seq Age Sex Outcome Treatment
    1