BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INZII RETRIEVAL SYSTEM

    MDR report key: 3042183 · Received March 27, 2013

    Report

    Report Number
    3042183
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 27, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING A 10MM ENDOPOUCH TO REMOVE A LAPAROSCOPIC SPECIMEN AND THE ENDOPOUCH RIPPED. IT WAS TAKEN OFF THE STERILE FIELD BY THE RN AND REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC APPENDECTOMY AND LAPAROSCOPIC RIGHT OOPHERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125705 INZII RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL TECHNOLOGY, INC * 1179776

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR