BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INZII RETRIEVAL SYSTEM 10 MM ENDOCATCH BAG

    MDR report key: 16984459 · Received May 22, 2023

    Report

    Report Number
    MW5117773
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 19, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INZII ENDOCATCH 10 MM BAG WAS DEPLOYED VIA TROCAR PORT, DURING DEPLOYMENT OF THE BAG, THE [INVALID]DID NOT CLOSE PROPERLY, BAG WAS PULLED BACK THROUGH THE TROCHAR PORT UNUSED AND SNAGGED ON IT'S WAY OUT. VISUAL INSPECTION WAS CONDUCTED ON THE BAG OWING TO THE UNUSUAL NATURE OF THE ENDOCATCH BAG'S REMOVAL. THE BAG WAS NOTED TO BE A LITTLE FRAYED, AND ONE OF THE [INVALID] APPEARED TO BE SMALLER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650008 INZII RETRIEVAL SYSTEM 10 MM ENDOCATCH BAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. 1462941

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other