BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3202788 · Received July 2, 2013

    Report

    Report Number
    3005075853-2013-03402
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    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
    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, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, A TEAR DROP-SHAPE CLIP WAS FED INTO THE JAWS AT THE 2ND AND 3RD FIRING. AGAIN A TEAR DROP-SHAPE CLIP WAS FORMED AT THE 3RD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO POSSIBILITY OF CRAMPING SOMETHING HARD. NO UNEXPECTED NOISE WAS HEARD. THERE WAS NO UNEXPECTED RESISTANCE AT THE FIRING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE OPERATION, THE DEVICE WAS FIRED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303072 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CN18

    Patients

    Seq Age Sex Outcome Treatment
    1