BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 7246206 · Received February 6, 2018

    Report

    Report Number
    2242352-2018-00110
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 12, 2018
    Report Date
    February 6, 2018
    Manufacturer
    MAQUET CV
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE WITHOUT EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION WAS PERFORMED. NO VISUAL DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ITS MECHANICAL FUNCTION. THE DEVICE WAS SECURELY ASSEMBLED 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 FLEXLINK ARM WAS SECURED IN POSITION WHEN THE KNOB WAS TURNED CLOCKWISE. THE KNOB DID TIGHTEN THE ARM. THE KNOB WAS THEN TURNED COUNTER-CLOCKWISE. THE FLEXLINK ARM LOOSENED AND BECAME MOVABLE ON ITS SWIVEL UP TO 180 DEGREES. IT WAS ALSO OBSERVED THAT THE MALLEABLE STABILIZER FOOT IS ABLE TO ROTATE WITH NO DIFFICULTY. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE MODE "MECHANICAL ISSUE" WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER CUSTOMER TRIED TO SET THE DEVICE ON THE ACTIVATOR DRIVE, THERE WAS A WOBBLE. ACCORDING TO THE DOCTOR, IT WAS FOUND THAT THE ARM OF THE DEVICE (THE LOCATION WHERE IT TURNS AROUND 180 DEGREE) WAS STIFF. ANOTHER PRODUCT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE GGJ SERVICE TECHNICIAN CHECKED THE RETURNED DEVICE AND WAS ABLE TO SET THE DEVICE TO THE UA-5001 WITHOUT ANY PROBLEMS. HOWEVER, HE FELT RESISTANCE ON THE ARM TURNING TOWARDS THE LOCKING LEVER SIDE AND IT STOPPED ON THE WAY.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER CUSTOMER TRIED TO SET THE DEVICE ON THE ACTIVATOR DRIVE, THERE WAS A WOBBLE. ACCORDING TO THE DOCTOR, IT WAS FOUND THAT THE ARM OF THE DEVICE (THE LOCATION WHERE IT TURNS AROUND 180 DEGREE) WAS STIFF. ANOTHER PRODUCT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE GGJ SERVICE TECHNICIAN CHECKED THE RETURNED DEVICE AND WAS ABLE TO SET THE DEVICE TO THE UA-5001 WITHOUT ANY PROBLEMS. HOWEVER, HE FELT RESISTANCE ON THE ARM TURNING TOWARDS THE LOCKING LEVER SIDE AND IT STOPPED ON THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89715 ACROBAT-I STABILIZER STABILIZER,HEART MWS MAQUET CV 25133716

    Patients

    Seq Age Sex Outcome Treatment
    1