BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2871651 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05668
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ASKU. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ASKU. WAS THERE ANY TORQUE OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ASKU. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ASKU. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ASKU. 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, AND FORMED THE REMAINING CLIPS AS INTENDED. HOWEVER, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE LOCKOUT POSTS WERE FOUND TO BE BROKEN WHICH SUGGEST THAT A LOCKOUT PREMATURE OCCURRED AND LEADING THE INCIDENT REPORTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND THE FINDING. 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE FIRING TO THE SIDE OF THE DEVICE AND NOT STRAIGHT. IT IS UNKNOWN IF ANY CLIPS FELL INTO THE PATIENT AND THE CALLER STATED THAT IF THE CLIPS DID FALL THEY WOULD HAVE BEEN RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H43X5P

    Patients

    Seq Age Sex Outcome Treatment
    1