BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTITCH 10MM SUTURING DEVICE

    MDR report key: 4008884 · Received June 27, 2014

    Report

    Report Number
    1219930-2014-00488
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON USED THE DEVICE WITH NO ISSUE. WHEN THE SURGEON RETURNED THE DEVICE TO THE SCRUB TECH TO UNLOAD THE USED NEEDLE, THE SCRUB TECH SAID T HE NEEDLE BROKE WHILE UNLOADING IT. THE NEEDLE BROKE WHEN SHE USED A GRASPER TO HELP REMOVE IT. THE SALES REP EXAMINED THE ENDOSTITCH AND THE DEVICE WAS STILL IN THE CLOSED OR LOCKED POSITION (METAL TABS WERE NOT UP/OUT). NO PATIENT HARM. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WA SNO DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT. NO OTHER MANUFACTURER'S REINFORCEMENT MATERIAL WAS USED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376654 ENDOSTITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3A0733X

    Patients

    Seq Age Sex Outcome Treatment
    1