BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2821106 · Received November 6, 2012

    Report

    Report Number
    3005075853-2012-05037
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. 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 INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2012. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? NO INFORMATION. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NO. 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. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY PROCEDURE, REGARDING THE DEVICE, THE CLIP FELL INTO THE PATIENT AT THE 4TH FIRING. THE FALLEN CLIP WAS REMOVED FROM THE PATIENT. WHEN THE DEVICE WAS FIRED OUTSIDE THE PATIENT, CLIPS FELL OUT AS WELL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H44Z4M

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPIC STAPLER