BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XS

    MDR report key: 2160807 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00805
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT SHAFT TIP SHRINK TUBING WAS DETACHED AND RECEIVED SEPARATELY. THERE WAS A SMALL TEAR ALONG ONE SIDE OF IT. THERE WAS SOME EVIDENCE OF BLOOD ON THE SCISSORS. THERE WAS EVIDENCE OF HEAT SHRINK SHAPE ALONG WHERE THE METAL PINS MOVE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "COVER DETACHED" 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 HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW 7X SCISSORS TIP OF THE BLACK COVER WAS OUT OF PLACE AND REMAINED IN THE PATIENT BODY. THE SURGEON HAD TO MAKE AN ADDITIONAL INCISION TO RETRIEVE THE PIECE UNDER DIRECT VISION. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XS VASOVIEW SCISSORS GEI MAQUET CARDIOVASCULAR, LLC VH-3100 25030687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other