BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PATH

    MDR report key: 492134 · Received October 29, 2003

    Report

    Report Number
    492134
    Event Type
    Malfunction
    Date Received
    October 29, 2003
    Date of Event
    June 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    ETHICON ENDO SURGERY, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS PHYSICIAN WAS REMOVING GRASPER FROM PORT DURING LAPAROSCOPIC PROCEDURE THE "REPOSABLE" SLEEVE BROKE, LEAVING HALF INSIDE THE PT'S ABDOMEN. PHYSICIAN WAS ABLE TO REMOVE THE BROKEN SLEEVE FROM THE PT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH SLEEVE GCJ ETHICON ENDO SURGERY, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other