BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC

    MDR report key: 9279236 · Received November 4, 2019

    Report

    Report Number
    MW5090862
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 20, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LAPAROSCOPIC APPENDECTOMY. DURING PROCEDURE, THE TIP OF PRODUCT BROKE OFF INTO THE PT. TIP WAS RETRIEVED. NO PT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070788 ESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS EMP60ECO-R 2846

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other