BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPINER TISSUE RETRIEVAL SYSTEM

    MDR report key: 6597846 · Received May 30, 2017

    Report

    Report Number
    6597846
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    April 8, 2017
    Report Date
    April 18, 2017
    Manufacturer
    ESPINER MEDICAL LTD.
    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

    ECO-SAC TISSUE RETRIEVAL LOOP PULLED OFF OF SAC WHEN SURGEON WAS ATTEMPTING TO PULL SAC WITH SPECIMEN OUT OF ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379925 ESPINER TISSUE RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ESPINER MEDICAL LTD. EMP50ECO-R 1585

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR