BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3211180 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03431
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 2013
    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). THE ANALYSIS RESULTS FOUND THAT THE 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 46 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.. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED WITH IT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY, THE KNIFE STOPPED ON THE WAY OF THE 4TH FIRING AND THE FIRING KNOB WAS BROKEN OFF BY FORCEDLY PUSHING. THE FIRING FORCE WAS MUCH HIGHER THAN EXPECTED. THE TARGET TISSUE WAS REGULAR.THE DEPLOYED STAPLES WERE FORMED PROPERLY. HOWEVER, THE STAPLE LINE WAS INCOMPLETE. THE DEVICE WAS FIRED ACROSS AN EXISTING STAPLE LINE. 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
    310761 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD SR75