BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4121582 · Received September 26, 2014

    Report

    Report Number
    1219930-2014-00890
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: THE COMPLAINT STATES THAT AFTER PROPERLY LOADING EVERYTHING, THE INSTRUMENT WOULD NOT FIRE AT ALL. THE NURSE SAID THAT ALL STATUS INDICATOR LIGHTS WERE ON IN SOLIDS AND THE FIRING STATUS INDICATOR LIGHT WAS ALSO FLASHING WHEN PUSHED THE GREEN BUTTON. AN ENDO GIA ULTRA UNIVERSAL BODY WAS USED INSTEAD TO FINISH THE PROCEDURE. TYPE OF PROCEDURE: LAPAROSCOPIC COLECTOMY MEDICAL INTERVENTION REQUIRED? NO. WAS RE-INTUBATION/RE-CANNULATION NECESSARY? NO. WAS SURGERY TIME EXTENDED BY 30 MINS OR MORE? NO. WHAT IS THE CURRENT CONDITION OF THE PATIENT? FINE. ADDITIONAL INFORMATION: PLEASE CONFIRM THAT PRODUCT WILL BE RETURNED FOR INVESTIGATION. RETURNED. 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? TRI-STAPLE RELOAD WAS USED. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO. IF YES, A. WHAT WAS THE BRAND OF THE REINFORCEMENT MATERIAL USED? WHAT WAS THE ITEM CODE AND LOT/SERIAL NUMBER OF THE REINFORCEMENT MATERIAL? WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM? NO. WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM? NO. IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. WAS THE DAMAGE IRREVERSIBLE? WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM? NO. DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION? NO. WHAT IS THE LAST KNOWN PATIENT STATUS? FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601762 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE STAPLING PRODUCT GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N4C1254UX

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIAADAPT, ENDO GIA ADAPTER STANDARD,