BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1950228 · Received December 9, 2010

    Report

    Report Number
    2242352-2010-03559
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT AND THE HOT JAW SILICON WAS CRACKED. THE DEVICE HAD EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS WERE FOUND TO BE OUT OF SPEC. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST, IT SELF-ACTIVATED. BASED UPON THIS, THE REPORTED FAILURE "DEVICE REMAINS ACTIVATED" IS 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 HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO INSTRUMENT LIT UP AND WOULDN'T TURN OFF. THEY TRIED SWAPPING THE CABLES, BUT IT STILL STAYED ON. A REPLACEMENT KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.

    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 25018267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA