BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECH MEDICAL SERVICE ENDO RETRIEVAL POUCH

    MDR report key: 13454344 · Received February 3, 2022

    Report

    Report Number
    MW5107206
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 1, 2022
    Manufacturer
    TECH MEDICAL SERVICES, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DEPLOYING APPARATUS DETACHED FROM THE MANIPULATING ROD, LEAVING THE APPARATUS INSIDE THE ABDOMEN. NO INJURY TO THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    THE DEPLOYING APPARATUS DETACHED FROM THE MANIPULATING ROD, LEAVING THE APPARATUS INSIDE THE ABDOMEN. NO INJURY TO THE PATIENT. DA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452388 TECH MEDICAL SERVICE ENDO RETRIEVAL POUCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ TECH MEDICAL SERVICES, INC. TM2002 6252003031

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female