BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INZII

    MDR report key: 5009866 · Received August 18, 2015

    Report

    Report Number
    5009866
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    June 14, 2015
    Report Date
    August 4, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    NLM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE INZII RETRIEVAL SYSTEM 10MM (REF CD001, LOT #1243360, EXP. 03-05-2018) FAILED TO FUNCTION PROPERLY AND POUCH WOULD NOT OPEN. A NEW DEVICE WAS OPENED AND USED WITHOUT DIFFICULTY. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544080 INZII LAPAROSCOPE, GENERAL & PLASTIC SURGERY NLM APPLIED MEDICAL RESOURCES CORP. 1243360

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR NONE THAT CAUSED OR CONTRIBUTED.