BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 13580118 · Received February 22, 2022

    Report

    Report Number
    2522007-2022-00005
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    December 30, 2021
    Report Date
    May 2, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: ITX. PMA/510(K): K171272. 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 · 0

    D2B: PRODUCT CODE: ITX. G5: PMA/510(K): K171272. THE DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN BY THEIR TESTIMONY. PER COMPLAINT: "ON (B)(6) 2021, AFTER THE MONITORING ENDED, AN UNEXPECTED OCCURRED WHEN THE PROBE WIRE WAS REMOVED (THE CRYSTAL SENSOR DID NOT DETACH FROM THE SILICONE CUFF AS NORMAL, BUT THE WIRE WAS INTERRUPTED, AND PART OF THE WIRE REMAINED IN THE PATIENT'S BODY), WE HAD A SUGGESTION AT THAT TIME THE CRYSTAL PROBE SHOULD BE REMOVED. THE SURGEON ALSO PERFORMED ANOTHER OPERATION TO REMOVE THE CRYSTAL PROBE ON (B)(6) 2022, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL NORMALLY AND SMOOTHLY." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. 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

    ON (B)(6) 2021 AFTER MONITORING HAD ENDED, AN UNEXPECTED EVENT OCCURRED DURING REMOVAL OF THE PROBE. THE CRYSTAL DID NOT DETACH AS NORMAL. THE WIRE BROKE AND REMAINED IN THE PATIENT'S BODY. ON (B)(6) 2022 A SURGEON PERFORMED AN ADDITIONAL OPERATION TO REMOVE THE CRYSTAL PROBE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL NORMALLY AND SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004918 COOK-SWARTZ DOPPLER PROBE ITX COOK VANDERGRIFT INC G21363 N181192 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention