BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 1935675 · Received December 2, 2010

    Report

    Report Number
    2027111-2010-00112
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 2, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS TO BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAP CHOLE- "BAG WAS DEPLOYED AND A MEDIUM SIZED GALL BLADDER PLACED. BAG BROKE AT THE BOTTOM, GALL BLADDER HAD CLEARED FASCIAL LAYER AND WAS IN SUBCUTANEOUS FAT LAYER WHEN BAG BROKE. GALL BLADDER REMOVED AND CONTAINED A LARGE STONE (1 1/2" LONG AND 1" DIAMETER). SURGEON FOUND A (HALF-MOON SHAPED) FRAGMENT OF BAG IN THE INCISION. ALL FRAGMENTS (ONE) RETRIEVED AND CASE CONCLUDED. BAG AND FRAGMENT WILL BE RETURNED. DR INSUFFLATED W/ VERCSS NEEDLE THEN PLACED A 12MM NON-BLADED EES TROCAR. AT REMOVAL, DID NOT EXTEND INCISION W/ BLADE, BUT DID STRETCH W/ A CLAMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM INZII RETRIEVAL SYSTEM 10/BOX MONARCH RETRIEVAL BAG GCJ APPLIED MEDICAL RESOURCES CD001 1124578

    Patients

    Seq Age Sex Outcome Treatment
    1