BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTC 400X

    MDR report key: 267065 · Received March 3, 2000

    Report

    Report Number
    1626598-2000-00010
    Event Type
    Malfunction
    Date Received
    March 3, 2000
    Date of Event
    February 2, 2000
    Report Date
    February 3, 2000
    Manufacturer
    UNITED STATES SURIGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS DURING A COLECTOMY. REPORTEDLY, THE INSTRUMENT BROKE AND A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTC 400X BLUNT TIP TROCAR GCJ UNITED STATES SURIGICAL CORP. NA 909017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN