BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR WAND CRYOTHERAPY SYSTEM

    MDR report key: 621238 · Received May 9, 2005

    Report

    Report Number
    621238
    Event Type
    Injury
    Date Received
    May 9, 2005
    Date of Event
    April 6, 2005
    Report Date
    May 4, 2005
    Manufacturer
    CHEK-MED SYSTEMS, INC./MYCOSCIENCE. INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EGD (ESOPHAGO-GASTRODUODENOSCOPY)FOR CRYOTHERAPY OF A GASTROINTESTINAL BLEED USING THE POLAR WAND DEVICE. THE PATIENT HAD A DISTENDED ABDOMEN AND BECAME PULSELESS. THE PATIENT RECEIVED CPR AND WAS ADMITTED TO THE ICU. THE PATIENT WAS EXTUBATED AND DISCHARGED HOME 24 TO 48 HOURS LATER AND IS CURRENTLY DOING OKAY. IT IS UNCERTAIN IF THE DEVICE CONTRIBUTED TO THIS EVENT HOWEVER THERE HAVE BEEN TWO OTHER INCIDENTS WITH THIS DEVICE IN APPROXIMATELY THE LAST YEAR. THE PAST PROCEDURES WERE NOT ALL PERFORMED BY THE SAME PHYSICIAN.FOLLOW UP REVEALS: THIS DEVICE WAS USED FOR ITS INTENDED USE AND THE DEVICE REPORTED WAS PART OF A SYSTEM. SUMMARY OF BIOMED ANALYSIS: (1)THE SPECIFICATIONS IN THE USER MANUAL ARE VIRTUALLY NON-EXISTENT.(2)THERE IS NOTHING ABOUT SAFETY FEATURES OR WARNINGS TO THE USER ABOUT THE VENTING OF GAS.(3)THE PRESSURE GAUGE IS NOT LABELED AND THE REGUALATOR NEXT TO IT CAN BE INADVERTENTLY ADJUSTED TO THE WRONG PRESSURE. (4)THE ELECTRONICS ARE POOR QUALITY AND THE LOW TANK INDICATOR LIGHT ISN'T WORKING. (5) THE PIPE FEEDING THE REGUALATOR IS BENT AND SOMEWHAT KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR WAND CRYOTHERAPY SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH CHEK-MED SYSTEMS, INC./MYCOSCIENCE. INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R