BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOPERSURGICAL

    MDR report key: 25334497 · Received May 29, 2026

    Report

    Report Number
    1216677-2026-00042
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 20, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 DURING A DIEP FLAP PROCEDURE, THE PHYSICIAN PLACED A COOK DOPPLER PROBE IN THIS PATIENT. IT WAS ACCIDENTALLY BROKEN AND NEEDED TO BE REPLACED. SIX PROBES WERE OPENED, AND NONE OF THEM WERE FUNCTIONAL. THE PATIENT WAS TAKEN OUT OF THE OPERATING ROOM WITHOUT AN IMPLANTED DOPPLER PROBE. FLAP MONITORING IS BEING ACCOMPLISHED WITH A PENCIL DOPPLER, WHICH IS LESS THAN OPTIMAL AND NOT THE USUAL STANDARD OF CARE. 1216677-2026-00042 DP-SDP001 SWARTZ PROBE 2026-05-0000369

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145921 COOPERSURGICAL SWARTZ DOPPLER PROBE ITX COOPERSURGICAL, INC. DP-SDP001 UNKNOWN 00888937027792

    Patients

    Seq Age Sex Outcome Treatment
    1