BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2030556 · Received March 18, 2011

    Report

    Report Number
    2242352-2011-00162
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D AND THE INVESTIGATION IS COMPLETED. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHEN THEY WERE DONE USING THE TOOL, SOMETHING BROKE OFF AND FELL IN THE STERILE FIELD. THEY BELIEVE THE VASOVIEW HEMOPRO JAWS OVERHEATED CAUSING THE JAWS TO SEPARATE AND FALL OFF IN MULTIPLE PIECES. THEY ARE PRETTY SURE THEY RECOVERED ALL THE PIECES. NO REPLACEMENT KIT WAS USED AS THE PROCEDURE WAS ALREADY COMPLETE. THERE WERE NO PT EFFECTS. IT IS UNK IF THE PRODUCT OR RELATED SYSTEM PRODUCTS ARE 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other