BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3916326 · Received June 2, 2014

    Report

    Report Number
    1219930-2014-00421
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ATYPICAL LUNG RESECTION. ACCORDING TO THE REPORTER: FIRST EVERYTHING WORKED FINE, GREEN LIGHT STATUS OKAY. THE INSTRUMENT FIRED THE RELOAD ONLY HALF, THEN IT COULD NOT BE FIRED ANY LONGER. THE RELOAD WAS OPENED AND SECOND STRAIGHT RELOAD USE WITH SINGLE USE INSTRUMENT. THERE WAS NO PATIENT INJURY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. NO ADVERSE EVENT WAS REPORTED DUE TO THE DELAY IN SURGERY. THERE WAS NO EXTENSION OF INCISION. NOTHING FELL INTO THE PATIENT CAVITY. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321239 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3H0806UX

    Patients

    Seq Age Sex Outcome Treatment
    1 #N3H0917UX, SERIAL #(B)(4), MANUF. DATE 08/2013| K102291.| EGIAADAPT, ENDO GIA ADAPTER STANDARD, LOT| EGIARADMT, ENDO GIA MEDIUM/THICK RADIAL RELOAD,