BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPINER TISSUE RETRIEVAL SYSTEM

    MDR report key: 6968182 · Received October 23, 2017

    Report

    Report Number
    6968182
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 18, 2017
    Manufacturer
    ESPINER MEDICAL LIMITED
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, DOCTOR PLACED THE BAG WITH A STICK IN THE ABDOMEN AND THE BAG SPLIT IN HALF AND BROKE WHILE PULLING THE APPENDIX OUT THROUGH A 5MM TROCAR HOE. NO PATIENT HARM AND NO PIECES RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748878 ESPINER TISSUE RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ESPINER MEDICAL LIMITED EMP50ECO-R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NO OTHER THERAPIES