BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC STAPLER

    MDR report key: 3955506 · Received July 24, 2014

    Report

    Report Number
    3005075853-2014-05193
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    June 30, 2014
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ¿SURGEON FIRED THE DEVICE IT STUCK¿, DOES THIS MEAN THE DEVICE PARTIALLY FIRED (STARTED TO STAPLE AND CUT BUT COULD NOT BE COMPLETED)? WERE THERE ANY ISSUES WITH OPENING THE DEVICE? DID THE BLADE NOT RETURN TO THE HOME POSITION? DID THE BLADE BECOME DISCONNECTED OR LOOSE FROM THE DEVICE? WERE THERE ANY PATIENT CONSEQUENCES?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SWING TAB IN LOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT THE NTLC55 INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL 2 DRIVERS 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 AUTOMATED VISION SYSTEM TO INSURE THE SWING TAB IS PRESENT AND UNLOCKED. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THE SURGEON FIRED THE DEVICE IT JUST STUCK AND THE BLADE OF CARTRIDGE CAME OUT FROM THE HOUSING. IT WAS THE SECOND FIRING DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434552 TLC STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E32P

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - SR75