BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.

    MDR report key: 2153194 · Received June 17, 2011

    Report

    Report Number
    2242352-2011-00661
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ULTIMA ACTIVATOR DRIVE MECHANISM KEPT SLIPPING, IT WAS NOT HOLDING THE CHEST OPEN. THE HOSPITAL ADDED THAT "THE MECHANISM THAT GRABS THE TRACK TO OPEN THE RETRACTOR IS NOT CATCHING WELL WHICH CAUSES SKIPPING AND DIFFICULTY OPENING THE STERNUM." THE SURGEON DID ASK FOR A DIFFERENT RETRACTOR IN ORDER TO PROCEED WITH THE CASE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. ULTIMA ACTIVATOR MWS MAQUET CARDIOVASCULAR, LLC UA-5001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA