BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR WAND CRYOTHERAPY SYSTEM

    MDR report key: 2023811 · Received March 8, 2011

    Report

    Report Number
    2529592-2011-00001
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 8, 2011
    Manufacturer
    GI SUPPLY
    Product Code
    GEH
    PMA / PMN Number
    K041783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OPERATED ACCORDING TO SPECIFICATIONS. NO DEVICE FAILURE.

    Description of Event or Problem · 1

    AN (B)(6), MALE, PT, WITH EARLY SQUAMOUS CELL CANCER OF THE MIDDLE ESOPHAGUS, UNDERWENT C02 BASED CRYOTHERAPY PROCEDURE OF THE MID PROCEDURE OF MILD ESOPHAGUS FOR ABLATION OF RESIDUAL DYSPLASTIC TISSUE AT A PREVIOUS RESECTION SITE. PT PRESENTED LATER THAT EVENING AT ER WITH ABDOMINAL PAIN. CT SCAN SHOWED FREE AIR IN THE PERITONEUM. SURGERY WAS SUBSEQUENTLY PERFORMED TO REPAIR 2 PERFORATIONS IN THE GASTRIC WALL. THE PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR WAND CRYOTHERAPY SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH GI SUPPLY GIS-19

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R