BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKELEY VACUUM CURETTAGE SYSTEM

    MDR report key: 5784862 · Received July 7, 2016

    Report

    Report Number
    MW5063330
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 7, 2016
    Manufacturer
    BERKELEY MEDEVICES
    Product Code
    HHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SEALING CAPS THAT ARE A PART OF THIS KIT DO NOT FIT SNUGLY, THEY ARE AS WE ARE TOLD DESIGNED TO SIT ON TOP THE CANISTER UNTIL SUCTION IS APPLIED. THIS DESIGN ALLOWS THE CAPS TO FALL OFF THE UNIT IF MOVED OR SHIFTED. THE KIT COMES WITH ONE CAP AND IF IT FALLS TO THE FLOOR ANOTHER ENTIRE KIT MUST BE OPENED. IF ATTEMPTS TO SECURE THE CAP TO THE CANISTER IS APPLIED THE CAP CRACKS THUS LOSING SUFFICIENT SUCTION TO PERFORM THE PROCEDURE. THE DESIGN OF THE CAP ATTACHMENT TO THE CANISTERS SHOULD BE EVALUATED FOR A BETTER AND SAFER DESIGN FOR EFFICIENCY, COST EFFECTIVENESS AS WELL AS PROPER USE OF THE EQUIPMENT. REASON FOR USE: UTERINE DILATATIONS AND CURETTAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430944 BERKELEY VACUUM CURETTAGE SYSTEM BERKELEY VACUUM CURETTAGE SYSTEM HHI BERKELEY MEDEVICES VC-10
    430945 BERKELEY SAFETOUCH TISSUE TRAP BERKELEY SAFETOUCH TISSUE TRAP HHK GYRUS ACMI

    Patients

    Seq Age Sex Outcome Treatment
    1