BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1811759 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04801
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN JAW; EJECTED CLIP; ANTI-BACKUP FAILURE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT WAS FIRED AND DUE TO THE ANTI BACKUP FEATURE BEING NON-FUNCTIONAL, TWO UNFORMED CLIPS WERE FED. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ATTEMPTING TO SQUEEZE THE DEVICE TRIGGER WHEN IT HAS NOT FULLY RETURNED OR STOPPING THE FIRING SEQUENCE AND PULLING THE TRIGGER OPEN. THE NEXT TWO CLIPS WERE CONFORMING AND THEN, DURING THE FOURTH FIRING SEQUENCE, THE RIGHT JAW RAMP BROKE; THE REMAINING CLIPS WERE EJECTED. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT COMPLETELY VISIBLE. THESE FINDINGS ARE NOT RELATED WITH THE INCIDENT REPORTED. NO OPENING ISSUES WERE NOTED DURING TESTING. 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 SURGEON FIRED THE 4TH CLIP AND THE DEVICE STUCK ON THE CYSTIC DUCT. HE MANUALLY FORCED THE DEVICE OPEN AND CONTINUED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT A LEAK OCCURRED IN THE INFLATION LINE DURING PT USE. THE CALLER REPORTED THAT VISUAL INSPECTION REVEALED A TEAR ON THE INFLATION LINE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1