BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2896465 · Received December 28, 2012

    Report

    Report Number
    2242352-2012-01362
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 5, 2012
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AT THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO DEVICE, A PIECE OF THE C-RING EXTENSION ARM ON THE HEMOPRO WAS OBSERVED TO BE MISSING. THE PIECE HAD BROKEN OFF INSIDE OF THE PT. THE PIECE WAS RETRIEVED USING THE HEMOPRO DEVICE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY ADD'L PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25058975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other