BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 3833847 · Received May 27, 2014

    Report

    Report Number
    2027111-2014-00263
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    August 11, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THAT THE SEAL WAS INTACT AND A TEAR HAD OCCURRED ON A PORTION OF THE DISTAL END OF THE BAG. IFU STATES "CARE SHOULD BE TAKEN TO AVOID CONTACT OF THE BAG WITH SHARP INSTRUMENTS, MORCELLATORS, CUTTING DEVICES AND ELECTROSURGICAL AND LASER INSTRUMENTS." THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE- "PULLED OUT A SMALL GALLBLADDER AND BAG BROKE. FAILED AS SOON AS THERE WAS PRESSURE ON BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311008 10MM INZII RETRIEVAL SYSTEM 10/BOX MONARCH RETRIEVAL BAG, CODE:GCJ GCJ APPLIED MEDICAL CD001 1215253

    Patients

    Seq Age Sex Outcome Treatment
    1