BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 82335 · Received February 19, 1997

    Report

    Report Number
    1628808-1997-00075
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 19, 1997
    Manufacturer
    EES-ALBUQUERQUE
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT HEMICOLOECTOMY THE TLC55 WAS FIRED ONCE WITH THE BLUE LOAD AND THEN TWO WHITE RELOADS. A THIRD WHITE CARTRIDGE WAS LOADED AND THE SURGEON COULD NOT ADVANCE THE FIRING KNOB. A TVC55 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 1/24/97 0955 LEFT MESSAGE AND 800# FOR SURGEON TO CALL BACK. 1/27/97 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GCJ EES-ALBUQUERQUE NA J41Y0L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other