BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18821525 · Received March 1, 2024

    Report

    Report Number
    8043817-2024-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    December 3, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN OOCYTE PUNCTURE WITH AN ENDOVAGINAL ULTRASOUND PROBE, THE PROBE COVER BROKE AFTER 2 TO 3 MINUTES. THE PROCEDURE WAS COMPLETED, AND THE PROBE COVER BROKE WHEN THE PROBE WAS REMOVED. AFTER VISUALIZING AN ECHO OPACITY DURING THE PROCEDURE, POOR ECHOGENICITY MADE THE PUNCTURE DIFFICULT. NO OTHER PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211768 MICROTEK INTRAOPERATIVE PROBE COVER PUI ECOLAB/MICROTEK INC 15344-00 6352LRI100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown