BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 14354891 · Received May 11, 2022

    Report

    Report Number
    2522007-2022-00013
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 10, 2022
    Report Date
    July 11, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: ITX. PMA/510(K): K17122. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. D2B - PRODUCT CODE: ITX . G5 - PMA/510(K): K17122. INVESTIGATION - EVALUATION THERE WAS NO DEVICE RETURNED ON THIS COMPLAINT BECAUSE IT WAS NOTED THAT THE DEVICE WAS DISPOSED OF, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD ONLY BE CONFIRMED OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE EVENT/COMPLAINT THAT WAS ENTERED AND REPORTED INTO TRACKWISE: "DIFFICULTY REMOVING PROBE." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. 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

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: AN (B)(6) FEMALE PATIENT UNDERWENT A MANDIBLE RECONSTRUCTION PROCEDURE IN WHICH THE COOK-SWARTZ DOPPLER PROBE, (B)(4), WAS USED. THE PHYSICIAN'S ASSISTANT WAS REQUESTED TO REMOVE THE PROBE AT FIVE DAYS POST-PROCEDURE. THE PROBE WAS NOT REMOVED UNTIL NINE TO TEN DAYS POST-PROCEDURE. WHEN ATTEMPTING TO REMOVE THE PROBE BLOOD STARTED FILLING UP AT THE INCISION SITE. THE PATIENT WAS TAKEN BACK TO POST-OP TO REMOVE THE PROBE AND HAVE A NEW PROBE PLACED ON ARTERY AT THE ANASTOMOSIS SITE. THE PATIENT DID WELL DURING THE SECOND PROCEDURE AND REPORTED DOING WELL THE DAY AFTER THE SECOND PROCEDURE.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: AN 87 YEAR OLD FEMALE PATIENT UNDERWENT A MANDIBLE RECONSTRUCTION PROCEDURE IN WHICH THE COOK-SWARTZ DOPPLER PROBE, G21363, WAS USED. THE PHYSICIAN'S ASSISTANT WAS REQUESTED TO REMOVE THE PROBE AT FIVE DAYS POST-PROCEDURE. THE PROBE WAS NOT REMOVED UNTIL NINE TO TEN DAYS POST-PROCEDURE. WHEN ATTEMPTING TO REMOVE THE PROBE BLOOD STARTED FILLING UP AT THE INCISION SITE. THE PATIENT WAS TAKEN BACK TO POST-OP TO REMOVE THE PROBE AND HAVE A NEW PROBE PLACED ON ARTERY AT THE ANASTOMOSIS SITE. THE PATIENT DID WELL DURING THE SECOND PROCEDURE AND REPORTED DOING WELL THE DAY AFTER THE SECOND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998145 COOK-SWARTZ DOPPLER PROBE ITX COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention