BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 4180779 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07182
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING KNOB. THE ANALYSIS RESULTS FOUND THAT THE NTLC75 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 ONE RELOAD PRESENT. THE RELOAD WAS RETURNED WITH THE PROXIMAL 44 DRIVERS UP WITHOUT STAPLES, AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT; THE SWING TAB IN THE LOCKED POSITION, WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. 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 THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IF ENOUGH FORCE IS APPLIED THE DEVICE COULD BE DAMAGED. IN ADDITION FAILURE TO COMPLETE THE STROKE MAY RESULT IN INCOMPLETE STAPLE LINE. FOR ADDITIONAL INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED WITH IT. 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, THE FIRING KNOB WAS BROKEN OFF AT THE 4TH FIRING OF FUNCTIONAL END TO END ANASTOMOSIS. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662950 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1