BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOPERSURGICAL

    MDR report key: 25028742 · Received April 29, 2026

    Report

    Report Number
    1216677-2026-00036
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 29, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    ITX
    UDI-DI
    00888937027792
    PMA / PMN Number
    K171272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN WHICH THE DOPPLER PROBE WAS USED. SURGEON COMPLAINS THAT THE NEW PROBES HAVE BEEN EXTREMELY QUIET AND HAS NOTICED A DIFFERENCE IN THIS CALENDAR YEAR. THE FLAP WAS LOST POST-OP. THE NURSES COULD NOT HEAR THE MONITOR WELL AND DID NOT NOTICE WHEN IT LOST SIGNAL. BY THE TIME THE SURGEON WAS CALLED IT WAS TOO LATE. FOLLOW-UP ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. DP-SDP001 SWARTZ PROBE 2026-04-0000273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096728 COOPERSURGICAL BLOOD FLOWMETER CATHETER, DOPPLER ITX COOPERSURGICAL, INC. DP-SDP001 UNKNOWN 00888937027792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H