BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOPERATIVE PROBE COVER

    MDR report key: 16086083 · Received December 30, 2022

    Report

    Report Number
    MW5114128
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    December 14, 2022
    Report Date
    December 28, 2022
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    PUI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SENTINEL PROBE BROKE THROUGH THE SENTINEL PROBE COVER. IT WAS DISCOVERED DURING THE PROCEDURE. AFTER THE SURGEON USED THE PROBE. HE LAID THE PROBE ON THE PTS ABDOMEN, THE SURGICAL TECH NOTED THE TIP IN THE COVER IMMEDIATELY AFTER USE. THE PROBE WAS IMMEDIATELY REMOVED FROM THE FIELD AND A TEGADERM WAS PLACED ON THE ABDOMEN WHERE THE PROBE LAID SURGEON IS AWARE OF THE EVENT AND DOES NOT SUSPECT A PIECE OF THE COVER TO BE IN THE PATIENT. NO KNOWN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765953 INTRAOPERATIVE PROBE COVER DRAPE, SURGICAL, EXEMPT PUI MICROTEK MEDICAL INC. D221489

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Other