BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3020989 · Received March 20, 2013

    Report

    Report Number
    2242352-2013-00265
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND THERE WAS SOME EVIDENCE OF BLOOD ON THE DEVICE. A VISUAL INSPECTION DID NOT IDENTIFY ANY NONCONFORMANCE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE; THE DEVICE PASSED THE PRE-CAUTERY TEST AS IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE HANDLE ON THE DEVICE WAS OPEN TO VERIFY THE INTERNAL CONNECTIONS; NO NONCONFORMITIES WERE IDENTIFIED. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE ACTIVATION TOGGLE ON THE HEMOPRO DEVICE MADE A CRUNCHING NOISE WHEN ACTUATED AND THE JAWS WERE STUCK OPEN. WHEN THE DEVICE WAS REMOVED FROM THE CANNULA, THE TOGGLE SWITCH WORKED PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116059 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25067690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA