BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3111034 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02304
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (A) WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION MAKING THE DEVICE NON-FUNCTIONAL. POSSIBLE CAUSES FOR THE CONDITION FOUND MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. DUE TO THE CONDITION OF THE RETURNED DEVICE IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) 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 REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # J92F5P, EXPIRATION DATE: 09/2017, MANUFACTURING DATE: 10/2012.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TORQUING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST DEVICE WAS MISFIRING. THE SECOND DEVICE SHOOTS CLIPS OUT BEFORE CLOSING. NO OTHER DETAILS ARE AVAILABLE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE. 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 TORQUING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213288 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CG0P

    Patients

    Seq Age Sex Outcome Treatment
    1