BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA OPCAB SYSTEM, STANDARD BLADE

    MDR report key: 2128690 · Received June 13, 2011

    Report

    Report Number
    2242352-2010-03105
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    September 7, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE, NO EVALUATION COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE AND AFTER THE FIRST ANASTOMOSIS, WHEN THE SURGEON TRIED TO UNSCREW THE ULTIMA OPCAB SYSTEM, IT WAS IMPOSSIBLE TO WITHDRAW THE ARM. IT WAS BLOCKED. THE SURGEON REPORTED, HE BELIEVES THE SCREW MECHANISM WAS BROKEN. HE HAD TO REMOVE THE STABILISATOR BY PUSHING THE HEART AWAY TO COMPLETE THE PROCEDURE, WITH NO PATIENT EFFECTS REPORTED. THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT IS NOT RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA