BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 17486661 · Received August 9, 2023

    Report

    Report Number
    2522007-2023-00011
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 16, 2023
    Report Date
    October 27, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FILL IN THE COMMON NAME/PRODUCT CODE/510K INFORMATION IF NEEDED, ¿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. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    G5 ¿ PMA/510(K): K17122. THE DEVICE WAS DISPOSED OF BY THE CUSTOMER PER TW. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "THE CLIP THAT WAS SECURING THE DOPPLER TO THE VEIN SLIPPED DOWN THE VEIN AND OCCLUDED THE BLOOD SUPPLY." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF 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

    PER REP - (B)(6) 2023 - THE CLIP THAT WAS SECURING THE DOPPLER TO THE VEIN SLIPPED DOWN THE VEIN AND OCCLUDED THE BLOOD SUPPLY. THE PATIENT ORIGINALLY HAD SURGERY ON (B)(6) 2023. THE PATIENT HAD TO RETURN TO THE O.R. ON (B)(6) 2023 DUE TO THE OCCLUDED BLOOD SUPPLY. THE CAUSE OF THE OCCLUDED VEIN WAS DETERMINED DURING THE RETURN TO THE O.R.

    Description of Event or Problem · 0

    PER REP - 07AUG2023 - THE CLIP THAT WAS SECURING THE DOPPLER TO THE VEIN SLIPPED DOWN THE VEIN AND OCCLUDED THE BLOOD SUPPLY. THE PATIENT ORIGINALLY HAD SURGERY ON (B)(6) 2023. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM ON (B)(6) 2023 DUE TO THE OCCLUDED BLOOD SUPPLY. THE CAUSE OF THE OCCLUDED VEIN WAS DETERMINED DURING THE RETURN TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904387 COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VANDERGRIFT INC N191902 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other