BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE BLUNT TROCAR WITH THREADED ANCHOR, 12MM

    MDR report key: 20843597 · Received December 3, 2024

    Report

    Report Number
    MW5163104
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 25, 2024
    Manufacturer
    COVIDIEN/COVIDIEN LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THORASCOPY, THE 12 BLUNT PORT PLASTIC TIP WAS BROKEN WHILE IN PATIENT'S CHEST. MD ATTEMPTED TO RETRIEVE ALL BROKEN PIECES IN PATIENT'S CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681942 VERSAONE BLUNT TROCAR WITH THREADED ANCHOR, 12MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN/COVIDIEN LLC BPT12STS J4C4171DY

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown