BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 7048197 · Received November 21, 2017

    Report

    Report Number
    2522007-2017-00045
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 28, 2017
    Report Date
    September 4, 2020
    Manufacturer
    COOK VANDERGRIFT 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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: COMPLAINT WAS EVALUATED AND CONFIRMED VIA CUSTOMER TESTIMONY. DEVICE WAS NOT RETURNED SO NO PHYSICAL INVESTIGATION COULD BE CONDUCTED. PRODUCT LITERATURE WAS REVIEWED AND THIS IS A KNOWN FAILURE MODE OF THE DEVICE WHICH WILL CONTINUE TO BE MONITORED ACCORDING TO ESTABLISHED COMPLAINT MONITORING PROCEDURES. A REVIEW OF THE DEVICE HISTORY RECORD AND MANUFACTURING AND QUALITY CONTROL RECORDS WAS CONDUCTED. THERE IS NO EVIDENCE THAT DEFECTIVE PRODUCT WAS MANUFACTURED USING CURRENT DRAWINGS AND DEVICE SPECIFICATIONS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: CHANGED TO TESTING OF ACTUAL/SUSPECTED DEVICE (10). H6- EC METHOD CODE DESC - 2: CHANGED TO HISTORICAL DATA ANALYSIS (4109). H6- EC RESULTS CODE DESC - 1: CHANGED TO MANUFACTURING PROCESS PROBLEM IDENTIFIED (170). H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO CAUSE TRACED TO MANUFACTURING (25). H10- ADDED SUMMARY OF INVESTIGATION. INVESTIGATION-EVALUATION: DEVICE WAS RETURNED TO CVI ON 20APR2020. THE DEVICE WAS USED. WHEN PERFORMING A VISUAL INSPECTION, THE CUFF WAS INDEED DETACHED FROM THE CRYSTAL. VISUAL INSPECTION CONFIRMED THE CUSTOMER'S COMPLAINT. THE PROBE WAS INSPECTED UNDER MAGNIFICATION, THERE IS EPOXY ON ONE SIDE OF THE CRYSTAL, AND THE OPPOSITE SIDE OF THE CRYSTAL DID NOT HAVE EPOXY REMAINING. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED NO SIGNS THAT THE CUFF WAS DETACHED PRIOR TO SHIPMENT OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATION. THIS IS A KNOWN FAILURE MODE, AND IS BEING TRACKED/TRENDED PER THE POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES AT CVI. CRYSTAL DETACHMENT FROM CUFF IS ADDRESSED PER CAPA 161942. A RISK ASSESSMENT WAS PERFORMED VIA QERA 171221.1. PER IFU (D00078672 REV003): "DEVICE SPECIFIC RISKS INCLUDE SEPARATION OF THE DOPPLER CRYSTAL FROM THE CUFF, INABILITY TO PERCUTANEOUSLY REMOVE THE CRYSTAL AFTER MONITORING IS COMPLETE, LOSS OF RECEPTION OR TRANSMISSION OF ULTRASOUND MONITORING SIGNAL." , "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." 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

    NO NEW INFORMATION REGARDING THE EVENT HAS BEEN REPORTED, HOWEVER THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR A PHYSICAL INVESTIGATION ON 20APRIL2020.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: ": (B)(6) ¿ THE CRYSTAL PREMATURELY SEPARATED FROM THE COVER AFTER THE SURGERY WAS COMPLETE. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR A SECOND SURGERY TO HAVE A NEW DOPPLER PUT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830491 COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VANDERGRIFT INC G21363 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.