BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23330535 · Received October 17, 2025

    Report

    Report Number
    8043817-2025-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 17, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS ROUTINELY SEEING HOLES IN STERILE PROBE COVER PC1293 DURING PROCEDURES, TYPICALLY NEAR DISTAL END OF PROBE TOWARD END OF CASE; OCCURS ~25% OF TIME WHEN USING MAGTRACE/ENDOMAG AND SCOUT PROBES. COVERS INSPECTED PRIOR TO USE; DEFECT NOTED AFTER PLACEMENT. RETURNED SAMPLE FROM SAME LOT DID NOT EXHIBIT HOLES. DEVICE HISTORY RECORD AND MANUFACTURING CONTROLS REVIEWED; NO NONCONFORMANCES IDENTIFIED. BASED ON USAGE CONTEXT AND TIMING, POTENTIAL USE-RELATED CONTRIBUTION (MISUSE) CONSIDERED MOST LIKELY; SPECIFIC MECHANISM NOT CONFIRMED. RISK ASSESSED AS LOW (CLINICIAN INCONVENIENCE). NO FIELD ACTIONS REQUIRED; INTERNAL AWARENESS ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER IS ROUTINELY SEEING HOLES IN STERILE PROBE COVER (PC1293) DURING PROCEDURES, TYPICALLY NEAR DISTAL END OF PROBE TOWARD END OF CASE. ISSUE OCCURS APPROXIMATELY 25% OF THE TIME WHEN USING MAGTRACE/ENDOMAG AND SCOUT PROBES. COVERS ARE INSPECTED BEFORE USE; DEFECT NOTED AFTER PLACEMENT. NO PATIENT INJURY REPORTEDNO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302200 MEDLINE-MICROTEK INTRAOPERATIVE PROBE COVER FEATURING ISOSILK¿, 8 CM X 244 CM (3 IN X 96 IN) PUI MICROTEK MEDICAL LLC PC1293 3055LR5000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown