BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    55MM SELECTABLE NEW TLC

    MDR report key: 4903497 · Received July 9, 2015

    Report

    Report Number
    3005075853-2015-04153
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 17, 2015
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING KNOB, DAMAGED SLIP BLOCK ASSEMBLY. BATCH # K5939R. ADDITIONAL INFORMATION RECEIVED: ON THE THIRD FIRING, DID THE DEVICE STAPLE? YES. IF YES, WAS THE STAPLE LINE COMPLETE? NO. ON THE THIRD FIRING, DID THE DEVICE CUT? YES. IF YES, WAS THE CUT LINE COMPLETE? NO. WILL ALL PIECES OF THE DEVICE BE RETURNED FOR ANALYSIS? NO INFORMATION. IF NO, WHAT IS THE DISPOSITION OF THE PIECES? NO INFORMATION THE ANALYSIS RESULTS FOUND THAT THE NTLC55 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AS THE FIRING KNOB WAS DETACHED AND THE SLIP BLOCK ASSEMBLY WAS NOTED TO BE DAMAGED. THE DEVICE WAS RECEIVED WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. THE DAMAGE TO THE FIRING KNOB AND SLIP BLOCK ASSEMBLY IS CONSISTENT WITH HIGH (OUTSIDE INDICATED USE) STAPLE FORMING FORCES; HOWEVER THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE HIGHER LOADS. 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. 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 A SEMI-OPEN COLECTOMY, THE FIRING KNOB WAS BROKEN OFF ON THE WAY OF THE THIRD FIRING OF FUNCTIONAL END TO END ANASTOMOSIS. NO PIECES FELL INTO THE PATIENT. 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
    447006 55MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1