BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2080940 · Received April 13, 2011

    Report

    Report Number
    2242352-2011-00273
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE TOOL WAS RECEIVED INSIDE THE CANNULA. THE CANNULA BLUNT TIP AND C-RING WERE MELTED. THE TISSUE WELDER COLD JAW SILICONE BOOT WAS COMPLETELY MELTED AND DETACHED. THE COLD JAW SILICONE BOOT WAS ALMOST COMPLETELY MELTED AND DETACHED. THERE WAS SOME EVIDENCE OF BLOOD. 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. BASED UPON THE OBSERVATION OF THE JAWS AND CANNULA TIP MELTED, THE REPORTED FAILURE "DEVICE REMAINS ACTIVATED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, TWO VASOVIEW HEMOPRO UNITS HAD ELECTRICAL FAILURES. THE FIRST UNIT OVERHEATED, MELTED THE JAWS AND TIP AND REMAINED ACTIVATED. THE SECOND, REPLACEMENT UNIT WOULD NOT CAUTERIZE, "CAUSING MORE BLEEDING." A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-3000 25029366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA