BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 4211817 · Received October 29, 2014

    Report

    Report Number
    2027111-2014-00331
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    July 30, 2014
    Report Date
    October 29, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE 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. ALL UNITS ARE 100% INSPECTED AND TESTED DURING THE MANUFACTURING PROCESS. 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

    (B)(4). NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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

    LAP HYSTERECTOMY WITH DAVINCI- "WHEN EXTRACTING THE ADNEX FROM THE PATIENT, THE SPECIMEN FELL OUT OF THE BAG. THERE WAS A HOLE IN THE BAG AND A PIECE OF PLASTIC IN THE PATIENTS CAVITY. THEY DECIDED TO USE A SECOND BAG AND THE SAME HAPPENED. IT LOOKED LIKE THE BOTTOM OF THE BAG HAD COME OFF REPEATEDLY, WHILE TRYING TO PULL OUT THE SPECIMEN IN THE CLOSED BAG. (AT NORMAL APPLICATION OF FORCE) -SEE (B)(4) - SAME PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692054 10MM INZII RETRIEVAL SYSTEM 10/BOX GCJ GCJ APPLIED MEDICAL CD001 1208560

    Patients

    Seq Age Sex Outcome Treatment
    1