BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.

    MDR report key: 2153213 · Received June 17, 2011

    Report

    Report Number
    2242352-2011-00651
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WAS GALLING ALONG THE INSIDE OF THE HANDLE KNOB. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. A FUNCTIONAL TEST WAS PERFORMED TO DETERMINE IF THE UNIT "SLIPS." THE ACTIVATOR DRIVE WAS TESTED TOO BY SLOWLY TURNING THE HANDLE CLOCKWISE AND COUNTER CLOCKWISE. THE DRIVE PERFORMED AS EXPECTED. BASED UPON THESE FINDINGS, THE REPORTED FAILURE MODE "MECHANISM KEPT SLIPPING" COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ULTIMA ACTIVATOR DRIVE MECHANISM KEPT SLIPPING, IT WAS NOT HOLDING THE CHEST OPEN. THE HOSP 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 HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA