BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1940634 · Received December 22, 2010

    Report

    Report Number
    2242352-2010-03770
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE DEVICE. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE VASOVIEW HEMOPRO HARVESTING TOOL AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST, THE TOOL DID NOT PRODUCE STEAM OR HEAT DURING SEVERAL ACTIVATIONS AND THE POWER SUPPLY LIGHTS DID NOT TURN ON OR BEEP. BASED UPON THE FUNCTIONAL TEST, THE REPORTED FAILURE "STOPPED WORKING" WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER SUPPLY STOPPED WORKING. THE STAFF TURNED OFF THE DEVICE AND UNPLUGGED THE POWER CORDS AND THEN ATTEMPTED TO POWER THE DEVICE BACK ON. THE GREEN LIGHT WAS NOT LIT. THE HARVESTER OPENED THE LEG TO HARVEST THE VEIN WITH NO ADDITIONAL PT EFFECTS REPORTED. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM HQO MAQUET CARDIOVASCULAR LLC VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other