BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 16145836 · Received January 12, 2023

    Report

    Report Number
    16145836
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    October 5, 2022
    Report Date
    December 28, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ENDO CATCH BAG STRING BROKE DURING LAP SLEEVE GASTRECTOMY SURGICAL CASE WHEN ATTEMPTING TO CLOSE THE BAG. SURGEON STATED THAT IT HAPPENED ON THE TWO PREVIOUS CASES AS WELL. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, ENDOPOUCH RETRIEVER (PER SITE REPORTER), ETHICON VENDOR REPRESENTATIVE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438042 ENDOPOUCH RETRIEVER LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC POUCH 895A27, 364A09

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA Female