BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3897139 · Received May 21, 2014

    Report

    Report Number
    2242352-2014-00585
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    WY-2013-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION SHOWED EVIDENCE OF DAMAGE ON THE JAWS. THE TIP OF THE SILICONE BOOT ON THE COLD JAW WAS MISSING AND NOT RETURNED. THIS PROBLEM IS CONSISTENT WITH THE IMPROPER INSERTION OF THE TOOL THROUGH THE CANNULA. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED PRE-CAUTERY TEST AND PERFORMED WITHIN SPECIFICATIONS. BASED ON THE EVAL RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, HOWEVER, IT WAS CONFIRMED FOR PEEL AND CRACK; SILICONE BOOT. A LOT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION ((B)(4)) ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TIP OF THE VASOVIEW HEMOPRO WAS BURNT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304016 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25092706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR