BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3850964 · Received February 12, 2014

    Report

    Report Number
    2242352-2014-00104
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    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 BOOTS DISPLAYED EVIDENCE OF HEAT RELATED DAMAGE CONSISTENT WITH ACTIVATION OF THE DEVICE WHILE THE JAWS ARE IN DIRECT CONTACT. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE DEVICE ALSO PASSED THE ENGINEERING 60 CYCLE LIFE TEST. THE HANDLE ON THE DEVICE WAS OPEN TO VERIFIED CONNECTIONS; WE DID NOT IDENTIFY ANY NON-CONFORMITIES. 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 NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO OVERHEATED AND WOULDN'T SHUT OFF; THE JAWS WERE GLOWING RED AND SMOKY. IT WAS NOTED THAT IT WAS HARD TO CONNECT THE EXTENSION CORD TO THE DEVICE. THE CORD AND THE DEVICE DID NOT CONNECT FULLY AND IT WAS ESTIMATED THAT THERE WAS A 1MM GAP. DURING TESTING OF THE DEVICE, IT ACTIVATED AND BEEPED NORMALLY FOR A SECOND, BUT WHEN THE ACTIVATION TOGGLE WAS RELEASED, THE DEVICE REMAINED ACTIVATED. A REPLACEMENT DEVICE WAS USED TO COMPLETED THE PROCEDURE, WHILE USING THE SAME EXTENSION CABLE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93777 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25089682

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR