BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA OPCAB SYSTEM, STANDARD BLADE

    MDR report key: 2117278 · Received May 20, 2011

    Report

    Report Number
    2242352-2011-00521
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 29, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT ONE SIDE OF THE BOTTOM OF THE MOUNT BASE HAD FRACTURED AND THE PIECE WAS NOT RETURNED. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. THE DEVICE WAS RECEIVED WITH THE STABILIZER MOUNT AND SHAFT KNOB ON HOUSING ASSEMBLY NOT TIGHTENED. THE DEVICE WAS SECURELY ASSEMBLED ONTO THE RETRACTOR BLADE BY HOOKING THE STABILIZER BASE ONTO THE RAIL. NEXT, THE STABILIZER SHAFT, KNOB, AND FOOT WERE TESTED FOR FUNCTIONALITY. PRESSURE WAS APPLIED ON THE STABILIZER FOOT TO TEST FOR STABILIZATION. THE STABILIZER SHAFT WAS SECURED IN POSITION WHEN THE LIGHT GRAY SIDE MOUNT KNOB WAS TURNED CLOCKWISE. THE STABILIZER FOOT WAS ALSO SECURED IN POSITION WHEN THE DARK GRAY KNOB WAS TURNED CLOCKWISE. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT "STABILIZER WOULD NOT LOCK IN PLACE" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ULTIMA STANDARD STABILIZER WOULD NOT LOCK IN PLACE. THE REPORTER CLARIFIED "THE KNOB WAS NOT TIGHTENING THE FOOT." STANDARD BLADES WERE BEING USED DURING THE PROCEDURE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA OPCAB SYSTEM, STANDARD BLADE ULTIMA STANDARD DWS MAQUET CARDIOVASCULAR, LLC OM-2001S NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA