BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4220536 · Received November 3, 2014

    Report

    Report Number
    1219930-2014-00993
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PROSTATECTOMY. ACCORDING TO THE REPORTER: UNIT SET UP PROPERLY. CLOSED ON TISSUE BUT DID NOT FIRE. MADE A VERY SHORT SOUND, BUT DID NOT ADVANCE. TISSUE WAS NOT TOO THICK. REASSEMBLED AND TRIED AGAIN. SAME RESULT. PUT SAME RELOAD ON DISPOSABLE HANDLE AND DID NOT FIRE. WAS LOCKED OUT. RELOAD EXAMINED WAS NOT PRE FIRED. SUBSEQUENTLY COULD NOT LOAD ANY RELOAD ONTO DEVICE. WE TRIED TO PUT TWO ADDITIONAL RELOADS ON WITH NO SUCCESS. RELOAD WOULD JUST NOT CONNECT TO ADAPTER. AND TRYING MADE THE RELOAD NOT ABLE TO BE FIRED ON DISPOSABLE. EVENTUALLY USED NEW RELOAD, NEW DISPOSABLE HANDLE TO FIRE ACROSS TISSUE. NO BUTTRESS MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702615 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N4G1188ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 PRODUCT NUMBER: EGIAADAPT