BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 7984751 · Received October 19, 2018

    Report

    Report Number
    3005075853-2018-13759
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    10705036001843
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # P94G5U. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 11 CONFORMING CLIPS. UPON TESTING, THE JAWS OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # P94G5U. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 11 CONFORMING CLIPS. UPON TESTING, THE JAWS OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, STIFF CLIPS DID NOT CLOSE PROPERLY. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823359 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. R4005R 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1