BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING CLIP APPLIER

    MDR report key: 3040899 · Received April 8, 2013

    Report

    Report Number
    3005075853-2013-01633
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 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
    JA
    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 AND FED AND FORMED ONE SCISSORED CLIP, 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE CLIP WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142759 LIGACLIP ENDOSCOPIC ROTATING CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1