BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS - ETS45MM

    MDR report key: 3932222 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04915
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = FIRING TRIGGER, LOCKOUT SPRING, WEDGE SLEDS. THE ANALYSIS RESULTS FOUND THAT THE CTS45 DEVICE WAS RECEIVED WITH THE FIRING TRIGGER DAMAGED AND WITH A TR45W CARTRIDGE LOADED IN THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED 1/2 WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON FIRED THE INSTRUMENT AND THE STAPLES FUNCTIONED CORRECTLY, FORMED CORRECTLY CREATING A STAPLE LINE ACROSS THE TISSUE. HOWEVER, THE INSTRUMENT DID NOT CUT THE TISSUE. A SECOND DEVICE WITH RELOAD 6R45B WAS USED AND INSTRUMENT STAPLED AND CUT CORRECTLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411006 ENDO LINEAR CUTTERS - ETS45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E83L

    Patients

    Seq Age Sex Outcome Treatment
    1 6R45W