BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3111616 · Received May 6, 2013

    Report

    Report Number
    2242352-2013-00419
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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
    TN, 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 EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SILICONE BOOT OF THE COLD JAW HAD CRACKED AND PIECES OF SILICONE WERE DISLODGED AND DID NOT RETURN. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TESTS; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. IT ALSO BEEPED WHEN ACTIVATED. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR BROKEN BOOT. 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 TIP OF THE HEMOPRO JAW HAD HEAT-RELATED DAMAGE AND DETACHED. NOTHING FELL INTO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196206 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25070877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA