BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER 3D9-3V

    MDR report key: 18064221 · Received November 3, 2023

    Report

    Report Number
    18064221
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 24, 2023
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    ITX
    UDI-DI
    00884838061545
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN EXAM WAS COMPLETE, PHILIPS TRANSVAGINAL PROBE BROKE IN HALF DURING ROUTINE TRANSVAGINAL EXAM, AS SONOGRAPHER WAS REMOVING PROBE FROM PATIENT. SONOGRAPHER NOTIFIED PHILIPS. THE ISSUE IS THE SAME ISSUE AS DESCRIBE IN A LARGE RECALL FOR SIMILAR DEVICES. HOWEVER, THIS PARTICULAR DEVICE IS NOT LISTED IN THE RECALL, SO PHILIPS WILL NOT COVER REPLACEMENT. MANUFACTURER RESPONSE FOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC, TRANSDUCER 3D9-3V (PER SITE REPORTER). THE MANUFACTURER WILL NOT COVER COST OF REPLACEMENT OF DEVICE. THE ISSUE IS THE EXACT SAME AS DEFECTS ON A RECALL LIST, BUT THIS PARTICULAR MODEL IS NOT ON THE LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042971 TRANSDUCER 3D9-3V TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND LLC 989605395622 B28BFQ 00884838061545

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Female