BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTOBASE RETRACTOR

    MDR report key: 535006 · Received March 5, 2004

    Report

    Report Number
    2135394-2004-00002
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 14, 2004
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES A SMALL PART FROM THE HANDLE OF THE UNIT FELL OFF WHILE RETRACTING DURING BYPASS. THE HCP INDICATED THE DETACHED PART WAS RETRIEVED INTRAOPERATIVELY FROM THE PT'S CHEST CAVITY WITH NO REPORTED CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOBASE RETRACTOR STERNOTOMY RETRACTOR DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 28701 1001052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention