BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3140094 · Received May 29, 2013

    Report

    Report Number
    2242352-2013-00507
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST AS IT SELF ACTIVATED. THE HANDLE ON THE DEVICE WAS OPEN TO VERIFY CONNECTIONS; DRIED BLOOD WAS FOUND ON THE SWITCH ACTUATOR WHICH WAS LIKELY ATTRIBUTABLE TO THE SELF-ACTIVATION OF THE DEVICE. BASED ON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY 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 HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO JAWS CONTINUED TO SMOKE AFTER CUTTING A VEIN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234764 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-300 25075134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA