BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INZII RETRIEVAL SYSTEM ENDOSCOPIC POUCH

    MDR report key: 8569087 · Received April 30, 2019

    Report

    Report Number
    MW5086289
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 26, 2019
    Report Date
    April 26, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE APPLIED MEDICAL RESOURCES CORP., INZII RETRIEVAL SYSTEM ACCORDING TO THE MFR'S INSTRUCTIONS. IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CINCH CLOSE THE ENDOSCOPIC POUCH. THE GALLBLADDER WAS ABLE TO BE REMOVED WITH THE OPEN POUCH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358705 INZII RETRIEVAL SYSTEM ENDOSCOPIC POUCH LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. CD001 1346511

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR