BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3944200 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05086
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 7, 2014
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: AT WHAT FIRING DID THE CLIP NOT HOLD? FROM THE FIRST FIRING ON. WHAT HAPPENED AFTER THE CLIP FELL OFF? A NEW DEVICE WAS OPENED. DID THE CLIP FALL INTO THE PATIENT? NO. IF SO HOW WAS THE CLIP RETRIEVED? DID THE RETRIEVAL OF THE CLIP ALTER THE PROCEDURE? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY BLEEDING OR LEAK WHEN CLIP FELL OFF OF TISSUE? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE EL5ML 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, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LAPAROSCOPIC COLON PROCEDURE, GEN11. THE DEVICE WAS DEFECTIVE AFTER ASSEMBLING. DEVICE: CLIPS DIDN´T HOLD. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422487 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E854

    Patients

    Seq Age Sex Outcome Treatment
    1