BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2111976 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02265
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 2011
    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). ADVANCER, TISSUE STOP. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TIP OF THE ADVANCER BROKEN AND WITH THE TISSUE STOP MISSING. THEREFORE, THE CLIPS COULD NOT BE FED AS INTENDED CAUSING PEAR SHAPED CLIPS. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE TISSUE STOP WAS MISSING. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE DEPLOYED CLIP WAS TEAR-DROP SHAPED AT THE 2ND FIRING. THEN THE TRIGGER BECAME NOT TO BE GRASPED ANYMORE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U96G

    Patients

    Seq Age Sex Outcome Treatment
    1