BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3

    MDR report key: 4432537 · Received January 15, 2015

    Report

    Report Number
    1124841-2015-00011
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    April 5, 2013
    Report Date
    January 5, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MWS
    Removal / Correction Number
    MD-2015-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT WAS PERFORMED BY ENDOSCOPIC TECHNOLOGIES, INC. PRIOR TO THE COMPLAINT BEING TRANSFERRED TO TERUMO CARDIOVASCULAR SYSTEMS. DURING THIS INVESTIGATION, THE EVENT WAS CONFIRMED. THE ACTUAL SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THAT THE CABLE WAS BROKEN. A REVIEW OF THE DEVICE HISTORY REVEALED NO ANOMALIES. THE ROOT CAUSE WAS DETERMINED TO BE WEAR AND TEAR OF THE CABLE AS A RESULT OF FREQUENT USE. OVER-TIGHTENING OF THE ARM OR MOVEMENT OF THE ARM CAN CONTRIBUTE TO CABLE WEAR AND/OR FRAYING. EVENT PROBLEM AND EVALUATION: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT (NOT LABELED). (B)(4). METHOD: ACTUAL DEVICE EVALUATED, VISUAL INSPECTION. RESULTS: END OF LIFE PROBLEM, DEGRADATION PROBLEM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSE EVENT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING PROCEDURE THE HERCULES 3 ARM BROKE WHILE TIGHTENING THE ARM. THIS EVENT BECAME ASSOCIATED WITH A SIGNED HEALTH HAZARD EVALUATION REPORT AND SUBSEQUENT SAFETY ALERT, MD-2015-001-C. THE HEALTH HAZARD REPORT WAS SIGNED ON DECEMBER 17, 2014. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37324 HERCULES 3 UNIVERSAL STABILIZER ARM MWS TERUMO CARDIOVASCULAR SYSTEMS CORP. 001-401-161 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK