BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYS, 10BX

    MDR report key: 5784096 · Received July 11, 2016

    Report

    Report Number
    2027111-2016-00520
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    May 31, 2016
    Report Date
    February 10, 2017
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE 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

    LAPAROSCOPIC CHOLECYSTECTOMY- "TOWARDS THE END OF THE PROCEDURE, WHEN THE BAG WAS DEPLOYED, THE BAG FELL OFF BOTH SIDES OF THE METAL PRONGS. PRONGS WERE EXPOSED INSIDE THE PATIENT. THEY TOOK THE INZII DEVICE OUT WITH NO PATIENT INJURY, AND NO BAG OR PIECES REMAINED INSIDE THE PATIENT. THIS HAPPENED BEFORE THE SPECIMEN WAS RETRIEVED, SO NO CONTENTS INSIDE THE BAG WHEN BAG FELL OFF.. OPENED A NEW INZII BAG TO FINISHED PROCEDURE." TYPE OF INTERVENTION: "N/A". PATIENT STATUS: "NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436620 CD001, 10MM RETRIEVAL SYS, 10BX GCJ GCJ AMR CD001 1267886 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1