BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC

    MDR report key: 1911075 · Received November 30, 2010

    Report

    Report Number
    3005075853-2010-06758
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH ONE SCISSOR CLIP. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE EJECTED THE REMAINING CLIPS AND THEN, IT LOCKED OUT AS INTENDED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND EJECTED CLIPS. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. 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, SCISSORING OCCURRED WHEN THE DEVICE WAS FIRED ON THE CYSTIC DUCT AND THE CYSTIC ARTERY. THE TISSUES WERE DAMAGED, BUT THE DOCTOR DEALT WITH THE PROBLEM RAPIDLY AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT TWO TO THREE DAYS AFTER INSTALLATION, THE 3D CROWN EXTERNAL BRACE HAD LOOSENED. AS PER PROCEDURE, THE DEVICE WAS RETIGHTENED. REPORTS THAT AFTER APPROX 2 WEEKS, THE DEVICE WAS STILL NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4TN3A

    Patients

    Seq Age Sex Outcome Treatment
    1