BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX ENDO CLIP APPLIER

    MDR report key: 5302356 · Received December 16, 2015

    Report

    Report Number
    3005075853-2015-08148
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 3, 2015
    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 # M92J88. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. 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 EIGHT CONFORMING CLIPS. IN ADDITION, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE DEVICE¿S INTERNAL COMPONENTS THE INSTRUMENT WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: CAN YOU CLARIFY HOW THE CLIP WAS NOT FED INTO THE JAWS PROPERLY. WAS THE CLIP FED SIDEWAYS INTO THE JAWS? --- NO INFORMATION WERE THE CLIPS FED SLOWLY INTO THE JAWS? --- NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, THE CLIP WAS NOT FED INTO THE JAWS PROPERLY. ALSO, THE DEPLOYED CLIP WAS MALFORMED EVEN AS IT WAS FED INTO THE JAWS PROPERLY. THE DEVICE WAS USED ON THE BLOOD VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831081 LIGAMAX ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1