BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 360

    MDR report key: 5033014 · Received August 26, 2015

    Report

    Report Number
    1124841-2015-00240
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    August 6, 2015
    Report Date
    September 14, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON AUGUST 26, 2015. (B)(4). THE ACTUAL SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT, DURING WHICH IT WAS CONFIRMED THAT THE LOCKING PLATES WERE BROKEN. THERE WAS NO DAMAGE OR INDICATION OF MISHANDLING ANYWHERE ON THE DEVICE. IT WAS NOTED THAT THE LOCKING PLATES FAILED AT THE HOLE WHERE THE STRESS WOULD BE THE GREATEST ON THE PART WHEN LOAD IS APPLIED. THE LOCK PLATES WERE MEASURED FOR THICKNESS AND WERE FOUND TO BE IN SPECIFICATION. FIVE UNUSED ARMS THAT HAD BEEN MANUFACTURED BY THE PREVIOUS OWNERS OF THIS PRODUCT, ENDOSCOPIC TECHNOLOGIES, INC., WERE SET UP ON THE INSTRON AND WERE CYCLED THOUGH 1000 USES. THE ARMS WERE SUBJECTED TO CYCLES OF EXTREME FLEXION AND RELAXATION, IN ORDER TO FORCE A FAILURE OF THE PLATES. THERE WERE NO FAILURES DURING THE TESTING OF THE FIVE SAMPLES. IT IS LIKELY THAT THE CAUSE OF THE PLATES FAILURE IS AN ABNORMAL USE CONDITION. THIS FAILURE IS LIKELY RELATED TO DAMAGE CAUSED TO THE LOCK PLATE INTEGRITY DURING RE-PROCESSING, WHICH WOULD BE STERILIZATION WHILE THE UNIT IS IN A LOCKED STATE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE HERCULES 360 ARM BROKE. THE ARM HAD BEEN USED FOR NINE CASES PREVIOUSLY, AND THEN IT WAS FOUND BROKEN. ACCORDING TO PICTURES PROVIDED BY THE USER FACILITY, IT LOOKS AS THOUGH LOCKING PLATES OR COMPONENTS BROKE OFF OF THE DEVICE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566650 HERCULES 360 UNIVERSAL STABILIZER ARM MWS TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 001-401-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1