BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 7138735 · Received December 21, 2017

    Report

    Report Number
    2522007-2017-00052
    Event Type
    Malfunction
    Date Received
    December 21, 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 Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, FOR A DEEP INFERIOR EPIGASTRIC PERFORATORS (DIEP) FLAP BREAST RECONSTRUCTION APPLICATION, THE PROBE WAS NOT GLUED WELL ENOUGH TO THE CUFF. AS A RESULT, THE DEVICE DID NOT WORK. NO OTHER INCIDENT INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE DEVICE 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
    917356 COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VASCULAR INC N/A 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1