BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 5831553 · Received July 28, 2016

    Report

    Report Number
    3005075853-2016-04272
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Report Date
    June 16, 2016
    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). BATCH # M92C65. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED WITH A CLIP UNFORMED IN THE JAWS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 2 CONFORMING CLIPS; IN ADDITION, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE DEVICE INTERNAL COMPONENTS THE INSTRUMENT WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE, THE RATCHET PAWL WAS FOUND DAMAGED CAUSING THE LOCKOUT FAILURE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS HAD A DIFFICULTY IN BEING OPENED. THE SAME DEVICE WAS CONTINUOUSLY USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482715 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1