BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 4264502 · Received November 7, 2014

    Report

    Report Number
    2242352-2014-01206
    Event Type
    Other
    Date Received
    November 7, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACROBAT-I VACUUM STABILIZER WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD. A VISUAL INSPECTION WAS PERFORMED. THERE WERE NO OBSERVABLE DEFECTS ON THE DEVICE. THE MALLEABLE STABILIZER FOOT WAS RECEIVED SLIGHTLY BENT BUT WAS ABLE TO BE RETURNED TO ITS ORIGINAL POSITION. THE DEVICE WAS SECURELY ASSEMBLES ONTO A REFERENCE RETRACTOR BLADE BY SLIDING THE STABILIZER BASE ONTO THE RAIL AND LOCKING THE LEVER. THE KNOB WAS EVALUATED FOR ITS ABILITY TO TIGHTEN THE FLEXLINK ARM WHILE THE LOCKING LEVER WAS IN BOTH THE LOCKED AND UNLOCKED POSITIONS. THE KNOB WAS ALSO EVALUATED FOR ITS ABILITY TO TIGHTEN THE FLEXLINK ARM WHILE LOCKED ON THE ACCESSRAIL PLATFORM BLADE. IN BOTH CASES, THE FLEXLINK ARM WAS SECURED IN POSITION WHEN THE KNOB WAS TURNED COUNTER CLOCKWISE. WE WERE NOT ABLE TO REPRODUCE THE ISSUE AS STATED IN THE EVENT DESCRIPTION. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT WAS NOT ABLE TO BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE KNOB WOULD NOT TIGHTEN ON THE ACROBAT-I STABILIZER ARM AND WOULD JUST SPIN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720673 ACROBAT-I STABILIZER CLAMP-LESS BEATING HEAR MWS MAQUET CARDIOVASCULAR, LLC OM-10000 25102897

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR