BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2240701 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03707
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SWING TAB IN LOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD LOADED IN THE INSTRUMENT. THE CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL ONE DRIVER UP AND THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. IT COULD NOT BE DETERMINED IF THE REPORTED INCIDENT WAS THE RESULT OF A PREMATURE LOCKOUT, OR THE RESULT OF AN INTERRUPTED FIRING STROKE. THE SWING TAB WAS RESET AND THE CARTRIDGE WAS LOADED INTO THE DEVICE FOR FUNCTIONAL TESTING. THE DEVICE ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, IT SHOULD BE NOTED THAT 100% INSPECTION IS PERFORMED BY MEANS OF (B)(4) TO INSURE THE SWING TAB IS PRESENT AND UNLOCKED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT STAPLE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TY9Z

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-SR75