BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INZII 10MM RETRIEVAL SYSTEM

    MDR report key: 18182218 · Received November 20, 2023

    Report

    Report Number
    MW5148338
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    January 20, 2022
    Report Date
    November 16, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JANUARY 20, 2022, PATIENT PRESENTED FOR LAPAROSCOPY, INCISIONAL/VENTRAL HERNIA REPAIR, AND GASTROTOMY. A LAPAROSCOPIC RETRIEVAL DEVICE, THE APPLIED MEDICAL INZII RETRIEVAL SYSTEM, WAS USED TO REMOVE A SPECIMEN. ON (B)(6) 2023, PATIENT FOUND TO HAVE ANOTHER HIATAL HERNIA WITH TRANSVERSE COLON CREATING A LARGE BOWEL OBSTRUCTION. PATIENT UNDERWENT A SURGICAL LAPAROTOMY WITH DIAPHRAGMATIC HERNIA REPAIR. DURING THIS SURGERY, A RETAINED OBJECT WAS FOUND AND REMOVED. IT WAS DETERMINED THAT THE OBJECT WAS THE GREEN GUIDE BEAD FROM THE INZII RETRIEVAL SYSTEM USED DURING THE (B)(6) 2022 SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124701 INZII 10MM RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. CD001

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other