BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23672083 · Received November 28, 2025

    Report

    Report Number
    8043817-2025-00010
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 28, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A MEDSUN REPORT FROM THE USER FACILITY DESCRIBING THAT MINI C-ARM DRAPES (PART NUMBER C9-008M) RIPPED DURING APPLICATION IN THE OPERATING ROOM. THE REPORT INDICATED THAT THREE DRAPES TORE IN THE SAME LOCATION DURING USE, AND TWO AFFECTED LOT NUMBERS WERE IDENTIFIED: 1115LR1300 AND 1135LR3400. THE MANUFACTURER INITIATED AN INVESTIGATION (COMPLAINT #(B)(4)) UPON BECOMING AWARE OF THE EVENT ON OCTOBER 29, 2025. DEVICE HISTORY RECORDS FOR THE AFFECTED LOTS WERE REVIEWED, AND HISTORICAL COMPLAINT DATA WAS ANALYZED. THE INVESTIGATION CONFIRMED THE NONCONFORMANCE AND IDENTIFIED THE ROOT CAUSE AS EQUIPMENT MALFUNCTION DURING THE SEALING PROCESS, LINKED TO INADEQUATE CONDITION OF THE TEFLON CLAMPING BARS ON SEALING MACHINE GRS-0001. PREVENTIVE MAINTENANCE AND CORRECTIVE ACTIONS WERE IMPLEMENTED, INCLUDING 100% INSPECTION OF ON-HAND INVENTORY AND CAPA-02462. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED. THE USER FACILITY REPORT WAS USED AS A PRIMARY SOURCE OF EVENT DETAILS AND CONTRIBUTED TO THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025, THAT MINI C-ARM DRAPES WERE PLACED BY A SURGICAL TECHNICIAN AND RIPPED DURING APPLICATION. THE RIP OCCURRED IN THREE DRAPES AT THE SAME LOCATION, AFFECTING PRODUCT C9-008M FROM LOTS 1115LR1300 AND 1135LR3400. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092812 MEDLINE-MICROTEK MINI C-ARM DRAPE SYSTEM FOR OEC 6800 PUI MICROTEK MEDICAL LLC C9-008M 1115LR1300, 1135LR3400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown