BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2982943 · Received February 22, 2013

    Report

    Report Number
    2242352-2013-00165
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS DETACHED FROM THE TIP OF THE HOT JAW. WHILE WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE DETACHED HEATER WIRE, THIS FAILURE IS CONSISTENT WITH THE IMPROPER INSERTION OF THE HEMOPRO 2 TOOL INTO THE HARVESTING CANNULA. PER THE IFU, WHEN INSERTING OR RETRACTING THE HARVESTING TOOL THROUGH THE HARVESTING CANNULA, CLOSE THE JAWS AND ENSURE THE JAW TIPS ARE ORIENTED UPWARDS (CONCAVE SIDE UP) TO PREVENT DAMAGE TO THE JAWS. BASED UPON THE EVALUATION RESULTS, 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO 2 JAWS BENT WHILE THE DEVICE WAS INSERTED INTO THE CANNULA. 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
    77547 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25068478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA