BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 7847762 · Received September 5, 2018

    Report

    Report Number
    2522007-2018-00018
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    June 24, 2018
    Report Date
    January 31, 2019
    Manufacturer
    COOK VASCULAR INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    PMA / PMN Number
    K022649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES: CHANGED TO YES. CHANGED TO PMA / 510(K): K171272. H3: CHANGED TO YES. H6: CHANGED DEVICE CODE DESC 1 UDIBLE PROMPT / FEEDBACK (4020). CHANGED EC METHOD CODE DESC 1 TESTING OF ACTUAL/SUSPECTED DEVICE (10). ADDED EC METHOD CODE DESC 2 ANALYSIS OF PRODUCTION RECORDS (3331). CHANGED EC RESULTS CODE DESC 1 APPROPRIATE TERM/CODE NOT AVAILABLE (4247). CHANGED EC CONCLUSIONS CODE DESC 1 CAUSE NOT ESTABLISHED (4315). EXPLANATION: EC RESULTS CODE DESC 1 APPROPRIATE TERM/CODE NOT AVAILABLE (4247): ALTHOUGH THE DEVICE WAS RETURNED FOR ANALYSIS, ONLY A PARTIAL INVESTIGATION COULD TAKE PLACE. A VISUAL INSPECTION WAS ABLE TO BE CONDUCTED HOWEVER AN FUNCTIONAL / ELECTRICAL EVALUATION OF THE DEVICE COULD NOT TAKE PLACE BECAUSE THE DEVICE WAS CUT INTO 3 PIECES BY THE USER RENDERING A ELECTRICAL EVALUATION OF THE DEVICE IMPOSSIBLE. INVESTIGATION SUMMARY: THE DEVICE WAS INSPECTED USING INCREASED MAGNIFICATION. THE CUFF WAS RETURNED FULLY ATTACHED TO THE CRYSTAL PER DESIGN. A FUNCTIONAL TEST COULD NOT BE PERFORMED ON THE PROBE AS THE CABLE WAS CUT IN TWO PLACES. ONE CUT WAS APPROXIMATELY 29CM FROM THE CRYSTAL (DISTAL TIP), AND THE OTHER CUT WAS APPROXIMATELY 97.5 CM FROM THE PROXIMAL CONNECTOR. EXCESS SOLDER OR ANY DEFECT OF THE SOLDER WAS NOT OBSERVED ON THE EDGE OF THE CRYSTAL WHERE THE TWO WIRES ARE SOLDERED TO THE CRYSTAL FACE. THE PROXIMAL END CONNECTOR COMPONENTS HAD NO SIGNS OF A DEFECT OR DAMAGE. THE CUSTOMERS COMPLAINT COULD NOT BE REPRODUCED AS THE DEVICE WAS RETURNED IN 3 PIECES FROM BEING CUT WITH A SHARP TOOL. THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT. A DEVICE HISTORY REVIEW WAS CONDUCTED, AND THERE IS NO EVIDENCE THAT DEFECTIVE PRODUCT WAS SHIPPED. THERE ARE NO SIGNS THAT THIS DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS PER REPORT ON (B)(6) 2018 A DOPPLER PROBE FAILED AND THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM FOR AN ADDITIONAL SURGERY.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CURRENTLY UNDER INVESTIGATION. THE ACTUAL DEVICE IS NOT CURRENTLY AVAILABLE, HOWEVER A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS PER REPORT ON (B)(6) 2018, A DOPPLER PROBE FAILED AND THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM FOR AN ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689350 COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER ITX COOK VASCULAR INC N147007 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention