BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P8-2TS

    MDR report key: 25163047 · Received May 13, 2026

    Report

    Report Number
    2221819-2026-00007
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    JOP
    UDI-DI
    06936415968854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MINDRAY REQUESTED THE PROBE FOR EVALUATION, THE CUSTOMER INDICATED THAT RETURN OF THE DEVICE IS PENDING COMPLETION OF AN INTERNAL ASSESSMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, IT WAS REPORTED THAT THE PROBE WAS OBSERVED TO HAVE A KINK. DURING INSERTION, AN ESOPHAGEAL INJURY WAS REPORTED. THE CUSTOMER DID NOT PROVIDE ADDITIONAL EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236112 P8-2TS P8-2TS PHASED ARRAY TRANSDUCER(TEE) JOP SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 120-021851-00 06936415968854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other