BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 4130581 · Received September 30, 2014

    Report

    Report Number
    1219930-2014-00902
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 22, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HEMORRHOID. ACCORDING TO THE REPORTER: GREEN BUTTON PRESSED AND FIRED DURING HEMORRHOIDPEXY PROCEDURE. HOWEVER, IT IS UNABLE TO RETRACT AND OPEN THE JAW OF THE RELOAD. PATIENT IS INVOLVED. ADDITIONAL INFORMATION 1. PLEASE CONFIRM THAT PRODUCT WILL BE RETURNED FOR INVESTIGATION. YES, STILL AT (B)(4) COVIDIEN AT THIS MOMENT 2. CAN YOU PROVIDE THE PRODUCT PROBLEM IN GREATER DETAIL? JAW UNABLE TO OPEN AFTER FIRING. TISSUE STILL CLAMP IN THE STAPLER. WHEN SURGEON PULLED THE HANDLE, IT'S NOT WORKING. 3. DID THE JAWS NOT OPEN BEFORE OR AFTER THE DEVICE WAS CLAMPED OVER TISSUE? SURGEON USED KNIFE TO CUT FOR THE TISSUE. 4. IF THE JAWS LOCKED AFTER CLAMPING ON TISSUE, HOW WAS THE DEVICE REMOVED FROM TISSUE? (CUT OFF, PRIED OPEN, OPENED BY FORCE, ETC.)UNABLE TO OPEN THE JAW. TISSUE STILL CLAMPED WITHIN THE JAW. 5. WHAT IS THE PRODUCT ID AND LOT NUMBER FOR THE RELOAD USED WITH THIS STAPLER? IF THE CUSTOMER CANNOT SUPPLY THE PRODUCT ID OR LOT NUMBER, WAS THE RELOAD A UNIVERSAL ROTICULATOR SULU, A STRAIGHT SULU, OR A TRI-STAPLE RELOAD? IT WAS TRI STAPLER. 6. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO A) IF YES, A. WHAT WAS THE BRAND OF THE REINFORCEMENT MATERIAL USED? B. WHAT WAS THE ITEM CODE AND LOT/SERIAL NUMBER OF THE REINFORCEMENT MATERIAL? 7. WHAT SURGICAL PROCEDURE WAS BEING PERFORMED? HEMORRRHOIDPEXY. 8. WHAT WAS THE DATE OF THE PROCEDURE? (B)(6) 2014. 9. WHAT IS THE PATIENT AGE, WEIGHT, GENDER? (B)(6). WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM? 11. WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM? NO. A. IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. B. WAS THE DAMAGE IRREVERSIBLE? 12. WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM? NO. 13. DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION? NO 14. WAS SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM? YES, EXTENDED TO 40 MINTUES A) WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? NO (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.?) 15. WHAT IS THE LAST KNOWN PATIENT STATUS? ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608761 EGIA ULTRA UNIVERSAL STAPLER REUSEABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIAUSTND N3C0068UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability UNKNOWN TRI STAPLE PRODUCT, K083519