BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 7133040 · Received December 20, 2017

    Report

    Report Number
    2522007-2017-00049
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 23, 2017
    Report Date
    February 15, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    PMA / PMN Number
    K022649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE WAS NOT RETURNED SO NO PHYSICAL INVESTIGATION COULD BE CONDUCTED. PRODUCT LITERATURE WAS REVIEWED. THIS IS A KNOWN FAILURE MODE OF THE DEVICE AND WILL CONTINUE TO BE MONITORED ACCORDING TO ESTABLISHED COMPLAINT MONITORING PROCEDURES. A QUALITY ENGINEERING RISK ASSESSMENT (QERA) WAS COMPLETED AND NO RISK REDUCTION IS NECESSARY. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT.

    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

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE CUFF PREMATURELY DISCONNECTED AFTER IT HAD ALREADY BEEN IMPLANTED IN THE PATIENT. THE DEVICE HAD TO BE REMOVED AND REPLACED WITH ANOTHER PROBE TO CORRECT THE CONDITION. THE CUSTOMER CONFIRMED THAT NO HARM CAME TO THE PATIENT, BUT IT WAS REPORTEDLY INCONVENIENT FOR THE STAFF INVOLVED. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913990 COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VASCULAR INC N/A 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1