BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5239803 · Received November 20, 2015

    Report

    Report Number
    2242352-2015-01291
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 26, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOVEMBER 20, 2015 11:30 AM (GMT-5:00) ADDED BY (B)(6): THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB C-RING WOULD NOT LOCK IN PLACE AND UPON CLOSER EXAMINATION THE SCOPE APPEARED TO PROTRUDE FURTHER THAN NORMAL FROM THE END OF THE CANNULA. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771278 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1