BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23878591 · Received December 23, 2025

    Report

    Report Number
    8043817-2025-00012
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 23, 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

    THE MANUFACTURER RECEIVED A COMPLAINT REPORTING THAT THE DEVICE EXPERIENCED TEARING DURING USE. NO LOT NUMBER, SAMPLES, PHOTOGRAPHS, OR ADDITIONAL SUPPORTING INFORMATION WERE PROVIDED; THEREFORE, DEVICE EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE REPORTER INDICATED THAT A SIMILAR ISSUE HAD BEEN PREVIOUSLY REPORTED; HOWEVER, DUE TO THE ABSENCE OF A LOT NUMBER OR OTHER DEVICE-SPECIFIC IDENTIFIERS, IT COULD NOT BE CONFIRMED WHETHER THIS EVENT INVOLVED THE SAME LOT OR DEVICE AS THE PRIOR REPORT. AN INVESTIGATION WAS CONDUCTED BASED ON AVAILABLE INFORMATION AND INCLUDED A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES, PROCESS CONTROLS, AND EQUIPMENT. NO NONCONFORMANCES WERE IDENTIFIED. A RISK ASSESSMENT DETERMINED THE RISK LEVEL TO BE LOW. BASED ON THESE FINDINGS, NO CORRECTIVE OR PREVENTIVE ACTIONS, HEALTH HAZARD EVALUATION, OR RECALLS WERE REQUIRED. THE ISSUE WILL BE TRACKED AND TRENDED IN ACCORDANCE WITH INTERNAL PROCEDURES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE STERILE PROBE COVER DRAPE (SKU PC1293) EXPERIENCED TEARING DURING USE IN THE OPERATING ROOM. THE COMPLAINT INVOLVED MULTIPLE UNITS; HOWEVER, THE LOT NUMBER WAS NOT PROVIDED, AND NO SAMPLES OR PHOTOGRAPHS WERE SUBMITTED DESPITE REQUEST. THE REPORTER INDICATED THAT A SIMILAR ISSUE HAD BEEN PREVIOUSLY REPORTED WITH THE SAME SKU, BUT DUE TO THE ABSENCE OF LOT-SPECIFIC INFORMATION, IT COULD NOT BE CONFIRMED WHETHER THIS EVENT INVOLVED THE SAME LOT AS THE PRIOR REPORT. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381410 MEDLINE-MICROTEK INTRAOPERATIVE PROBE COVER FEATURING ISOSILK¿, 8 CM X 244 CM (3 IN X 96 IN) PUI MICROTEK MEDICAL LLC PC1293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown