BEUDAMED
    FDA Adverse Event Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 3020575 · Received March 20, 2013

    Report

    Report Number
    2027111-2013-00082
    Date Received
    March 20, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 20, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT NUMBER 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 ADD'L INFO, WHICH WAS NOT KNOW 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 CHOLE - "SURGEON PERFORMED LAP CHOLE. WHEN TRYING TO REMOVE THE SPECIMEN, WITH A LARGE STONE, OUT OF THE PT THE BAG BROKE AT THE BOTTOM OF THE BAG (FURTHEST AWAY FROM THE GUIDE BEAD)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116588 10MM INZII RETRIEVAL SYSTEM 10/BOX MONARCH RETRIEVAL BAD GCJ APPLIED MEDICAL CD001 1179570

    Patients

    Seq Age Sex Outcome Treatment
    1