BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTOPUS 4

    MDR report key: 551037 · Received April 16, 2004

    Report

    Report Number
    2135394-2004-00004
    Event Type
    Malfunction
    Date Received
    April 16, 2004
    Date of Event
    March 17, 2004
    Report Date
    March 17, 2004
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFO REC'D INDICATES THAT DURING SURGERY THE CLAMP COVER REPORTEDLY CAME OFF THE DEVICE CLAMP. THE COVER WAS RETRIEVED INTRAOPERATIVELY AND A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. NO REPORTED CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOPUS 4 TISSUE STABILIZER DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 29400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other