BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP57 ULTRASOUND PROBE

    MDR report key: 6976121 · Received October 25, 2017

    Report

    Report Number
    6976121
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 20, 2017
    Manufacturer
    BK MEDICAL APS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE RUBBER SEAL FRACTURE ON THE ULTRASOUND DEVICE CRACKED AND FELL INTO THE SURGICAL SITE. THE BLACK PIECES WERE RETRIEVED. THE VENDOR WAS NOTIFIED REGARDING EVENT AND EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755916 IP57 ULTRASOUND PROBE TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS 8826

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NOT APPLICABLE.