BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 8236416 · Received January 10, 2019

    Report

    Report Number
    3005075853-2019-15673
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 19, 2018
    Report Date
    December 19, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # R94M14. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN ADDITION, 2 CLIPS PROPERLY FORMED WERE RETURNED INSIDE OF A PLASTIC BAG. 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 5 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). DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN ADDITION, 2 CLIPS WITH GAP NOT PROPERLY FORMED WERE RETURNED INSIDE OF A PLASTIC BAG. 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 5 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.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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 LAPAROSCOPIC CHOLECYSTECTOMY, THE DOCTOR FIRED TWO CLIPS ON TISSUE AND THE TWO CLIPS HAD FALLEN OFF THE TISSUE. THE DOCTOR RETRIEVED THE CLIPS FROM THE PATIENT AND USED A SECOND LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26393 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. R94M14 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1