BEUDAMED
    FDA Adverse Event Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 2347544 · Received November 16, 2011

    Report

    Report Number
    2027111-2011-00109
    Date Received
    November 16, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 16, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATE TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAPAROSCOPIC SALPINGO OPHORECTOMY - "THE INZII BAG SPLIT WHEN TRYING TO PULL THE SPECIMEN THROUGH THE PORT SIDE. A SMALL PIECE OF PLASTIC BROKE OFF AND COULD NOT BE RECOVERED. A SECOND INZII BAG WAS OPENED TO RETRIEVE THE SPECIMEN. THE ASSIST MD GRABBED THE BAG WITH A GRASPER AND PUNCTURED ANOTHER HOLE IN THE SECOND BAG LOT# 1150614. THE FIRST BAGS LOT NUMBER IS 1148046.". PATIENT STATUS: STABLE. TYPE OF INTERVENTION: IRRIGATED WITH SALINE AND SUCTIONED TO TRY AND RETRIEVED THE SMALL PIECE OF PLASTIC. UNABLE TO DETERMINE IF IT WAS LEFT IN THE PT OR IN THE SUCTION CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM INZII RETRIEVAL SYSTEM 10/BOX MONARCH RETRIEVAL BAG GCJ APPLIED MEDICAL CD001 1148046/1150614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention