BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 3250964 · Received May 23, 2013

    Report

    Report Number
    3250964
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 23, 2013
    Manufacturer
    STERILMED, INC
    Product Code
    NLM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN PREPARING ROOM FOR SURGERY, WHEN THIS ITEM WAS OPENED IT LITERALLY FELL APART.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NOT APPLICABLE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228960 ENDOPATH XCEL TROCAR NLM STERILMED, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *