BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUB VACUUM STABILIZER SYSTEM, ST

    MDR report key: 2872532 · Received December 12, 2012

    Report

    Report Number
    2242352-2012-01308
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT SUV VACUUM STABILIZER LOCK LEVER FRACTURED WHEN THE DEVICE WAS REMOVED FROM THE RETRACTOR. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT SUB VACUUM STABILIZER SYSTEM, ST CLAMPLESS BEATING HEART MWS MAQUET CARDIOVASCULAR, LLC. OM-9000S 25065446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA