BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 2870694 · Received December 12, 2012

    Report

    Report Number
    3005075853-2012-05643
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    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. IN ADDITION THE STAPLE SELECTOR WAS NOTED TO BE BROKEN. THE DEVICE WAS RECEIVED WITH ONE RELOAD PRESENT. THE RELOAD WAS RETURNED WITH THE PROXIMAL 48 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 ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION PROVIDED: WAS THE SURGEON AND O.R. STAFF THOROUGHLY IN-SERVICED ON THE STEPS OF USE PRIOR TO THE USE OF THE NTLC?---YES. WAS THE REP PRESENT FOR THIS CASE? ---NO. WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? ---GOLD. WAS THE CARTRIDGE LOADED WITH THE RETAINING CAP ON? ---NO INFORMATION. DID ANYONE MOVE THE FIRING KNOB TO THE LEFT OR RIGHT AFTER LOADING THE DEVICE BUT BEFORE FIRING? ---NO. WAS BUTTRESSING MATERIAL UTILIZED? ---NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO. WERE ANY UNEXPECTED NOISES HEARD? ---NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---FIRING FORCE WAS HIGHER. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---NO. DID THE DEVICE CUT THE TISSUE? ---YES. WHAT WERE THE QUALITY AND/OR THICKNESS OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? (FRIABLE, THIN, REGULAR, THICK, ETC.)? ---REGULAR. IF THE DEVICE LOCKED OUT, DID IT LOCK OUT ON TISSUE OR PRIOR TO USE ON TISSUE? ---ON TISSUE. WAS THE FIRING TO CLOSE AN OSTOMY? ---NO. WAS ANOTHER STAPLING DEVICE INVOLVED? (I.E., CDH, TL, TX, ETC.) ---NO. WHAT WERE THE PATIENTS PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENTS HEALTH/SURGICAL OUTCOME? ---NO INFORMATION. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? ---NO INFORMATION. WHAT PREDICATE DEVICE WAS USED BY THE SURGEON? ---NO INFORMATION. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? ---NO INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE FIRING KNOB WAS BROKEN OFF AT THE 4TH FIRING. THE STAPLES WERE NOT DEPLOYED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. REINFORCEMENT MATERIAL WAS NOT USED. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J5HL5P

    Patients

    Seq Age Sex Outcome Treatment
    1