BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 18010747 · Received October 26, 2023

    Report

    Report Number
    2522007-2023-00023
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    September 14, 2023
    Report Date
    January 26, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. G5 ¿ PMA/510(K): 171272. THE ENTIRE DEVICE WAS NOT RETURNED - ONLY SIX SMALL PIECES OF WIRE WERE RETURNED ON THIS COMPLAINT. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "EXPLANTING THE DOPPLER PROBE RESULTED IN AN INCOMPLETE REMOVAL OF THE PROBE." THE QUALITY ASSURANCE DEPARTMENT PERFORMED THE INVESTIGATION OF THIS DOPPLER PROBE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO ONLY SIX SMALL PIECES OF WIRES BEING RETURNED. PER CUSTOMER COMPLAINT INFORMATION: "EXPLANTING THE DOPPLER PROBE RESULTED IN AN INCOMPLETE REMOVAL OF THE PROBE. THE REMOVED PART WAS DISPOSED, THE DISTAL PART OF THE PROBE LEFT IN SITU. IT IS NOT CLEAR YET WHETHER THE INCOMPLETE REMOVAL IS DUE TO CUTTING OR TEARING OFF. A MEETING WITH THE DR. TO COMPLETE THIS INFORMATION COULD NOT TAKE PLACE EARLIER, AND IS SCHEDULED ON 24TH OCTOBER. NONETHELESS WE WANTED TO PROVIDE YOU THIS INFORMATION ALREADY." AND PER CUSTOMER COMPLAINT ATTACHMENT, THE WIRES RETURNED WERE STATED TO HAVE BEEN THE ONES THAT WERE SURGICALLY REMOVED BY STAFF THAT MAY HAVE USED AN INSTRUMENT PULLING THE PROBE, WHICH COULD EXPLAIN SOME OF THE DAMAGES." THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. DURING THE VISUAL INVESTIGATION, THERE WAS BLOOD PRESENT ON THE WIRES ALONG WITH A BLOOD CLOT/CALCIFICATION PRESENT ON THE WIRE. THE ENDS OF THE WIRES WERE APPEARING THINNER THAN THE WIRE ITSELF AND SOME APPEAR TO HAVE A MILD TWIST IN THEM. THE PIECE THAT WAS RETURNED WITH THE CRYSTAL SHOWED THAT THERE WAS EPOXY PRESENT ON THE CRYSTAL AND THE WIRE WAS ATTACHED TO BOTH SIDES OF THE CRYSTAL. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING QUALITY CONTROL AND MANUFACTURING RECORDS. THERE WERE NO SIGNS OF A MANUFACTURING NONCONFORMITY FOUND OR THAT THE DEVICE WAS SHIPPED TO THE FIELD NONCONFORMING. THE COMPLAINT WILL BE MONITORED PER THE COOK VANDERGRIFT INC. COMPLAINT HANDLING AND POST MARKET SURVEILLANCE 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. G5 ¿ PMA/510(K): 171272. 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.

    Description of Event or Problem · 0

    EXPLANTING THE DOPPLER PROBE RESULTED IN AN INCOMPLETE REMOVAL OF THE PROBE. THE REMOVED PART WAS DISPOSED, THE DISTAL PART OF THE PROBE LEFT IN SITU. IT IS NOT CLEAR YET WHETHER THE INCOMPLETE REMOVAL IS DUE TO CUTTING OR TEARING OFF. A MEETING WITH THE DR. TO COMPLETE THIS INFORMATION COULD NOT TAKE PLACE EARLIER, AND IS SCHEDULED ON 24TH OCTOBER. NONETHELESS WE WANTED TO PROVIDE YOU THIS INFORMATION ALREADY.

    Description of Event or Problem · 0

    EXPLANTING THE DOPPLER PROBE RESULTED IN AN INCOMPLETE REMOVAL OF THE PROBE. THE REMOVED PART WAS DISPOSED, THE DISTAL PART OF THE PROBE LEFT IN SITU.IT IS NOT CLEAR YET WHETHER THE INCOMPLETE REMOVAL IS DUE TO CUTTING OR TEARING OFF. A MEETING WITH THE DR. TO COMPLETE THIS INFORMATION COULD NOT TAKE PLACE EARLIER, AND IS SCHEDULED ON 24TH OCTOBER. NONETHELESS WE WANTED TO PROVIDE YOU THIS INFORMATION ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216930 COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VANDERGRIFT INC N185885 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DP-CAB01| DP-CAB01| DP-M350| DP-M350