BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3140036 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02696
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 10, 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). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: IN THE EVENT IT STATED THAT THE DEVICE BECAME CLOSED? YES. DOES THIS MEAN THAT THE DEVICE WOULD NOT OPEN? YES. IF SO HOW WAS THE DEVICE REMOVED FROM TISSUE? THE DEVICE DID NOT CLAMP THE TARGET TISSUE AT THE INCIDENT. WAS THERE ANY TISSUE DAMAGE? NO. IF SO HOW WAS THE DAMAGED TISSUE REPAIRED? NA. AT WHAT FIRING DID THE CLIP NOT DEPLOY FROM THE DEVICE? THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE ANY TORQUING OR TWISTING WHEN FIRING THE DEVICE? NO. WERE THERE ANY UNUSUAL NOISE HEARD DURING FIRING? THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID THE PRIMARY SURGEON FIRE THE DEVICE? YES. IS THIS THE FIRST TIME THAT THE SURGEON HAS USED THE DEVICE? THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THE CLIP FULLY ADVANCED IN THE JAWS PRIOR TO FIRING? NO.

    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. 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 THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP COULD NOT BE DEPLOYED AND THE JAWS BECAME CLOSED WHEN THE DEVICE WAS USED FOR THE GALLBLADDER ARTERY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS WASHED AND IT WAS RETURNED WITH JAWS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241023 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C976

    Patients

    Seq Age Sex Outcome Treatment
    1