BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3063342 · Received April 11, 2013

    Report

    Report Number
    2242352-2013-00342
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD ON THE DEVICE. VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS BENT AND DETACHED FROM THE TIP OF THE HOT JAW. BASED UPON THE REVIEW CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS 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 HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE METAL TIP ON THE HEMOPRO 2 JAW WAS BENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154753 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25071718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA