BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2141010 · Received June 21, 2011

    Report

    Report Number
    2242352-2011-00675
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE BACK OF THE COLD JAW SILICONE BOOT HAD A SMALL TEAR. THE JAWS WERE BURNT. THE TISSUE WELDER WAS RECEIVED INSIDE THE CANNULA. THE CANNULA LEFT HANDLE HAD A CRACK SEVERAL CM LONG NEAR THE TIP DISTAL SCREW. 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 FUNCTIONAL TEST, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AS NO ELECTRICAL MALFUNCTION COULD BE IDENTIFIED. BASED UPON THE VISUAL OBSERVATIONS OF THE JAW BOOT PEEL AND CANNULA CRACK, THE DEVICE DID NOT MEET SPECIFICATION AND THE FAILURE MODE "PEEL, CRACK" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE USING THE VASOVIEW HEMOPRO TO HARVEST, THE HARVESTER DID NOT REALIZE HOW CLOSE THEY WERE TO THE SKIN AND BURNED THE PT. SILVADENE CREAM WAS APPLIED TO BURNT AREA. THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY OTHER PT EFFECTS. THE PRODUCT WAS RETURNED. THE REPORTER STATED THAT THIS WAS MORE A USER ERROR THAN PRODUCT MALFUNCTION. THE SIZE OF THE BURN WAS VERY SMALL.

    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 25033212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other