BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 4252348 · Received November 14, 2014

    Report

    Report Number
    2027111-2014-00324
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    April 28, 2014
    Report Date
    November 14, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE PRODUCT OF THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE COMPLETE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT REVEALS THE LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE, "NOTE: IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." WHEN THE INCISION IS ENLARGED, THE SPECIMEN CAN BE REMOVED WITHOUT INCIDENT. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS FOLLOW UP THE MW5036337. THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED 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.

    Description of Event or Problem · 1

    VOLUN 03-JUN-2014: "GALLBLADDER RETRIEVAL BAG BROKE RELEASING GB CONTENTS AND PIECES OF PLASTIC FROM THE BAG INTO THE PT'S ABDOMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736149 10MM INZII RETRIEVAL SYSTEM 10/BOX GCJ GCJ APPLIED MEDICAL CD001 1213089

    Patients

    Seq Age Sex Outcome Treatment
    1