BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-SYSTEMS

    MDR report key: 23816252 · Received December 16, 2025

    Report

    Report Number
    1216677-2025-00057
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    October 31, 2025
    Report Date
    February 19, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    PUB
    UDI-DI
    00888937023985
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS SERVICED IN THE FIELD AND WILL NOT BE RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H4, H6, H11. CORRECTION: D4. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM UAB LIFE INSTRUMENTS ON 3/13/25 AND SOLD ON 7/23/25. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. NOTE: OBSERVED AND CORRECTED BY THE DISTRIBUTOR'S SERVICE TEAM, THEREFORE, THE COMPLAINT IS CONFIRMED. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED FOR THIS ISSUE AT THIS TIME, HOWEVER, THERE'S POTENTIAL THE SCREWS WERE LOOSENED IN TRANSIT OR AS A RESULT OF REPEATED HEATING AND COOLING CYCLES. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    THE WORKSTATION WAS INSTALLED ON (B)(6) 2025. DURING INSTALLATION TEST, THE EQUIPMENT FUNCTIONED PROPERLY. ON (B)(6), THE CUSTOMER CONTACTED THE DISTRIBUTOR BECAUSE THE LEFT WORK AREA STOPPED HEATING AND THAT THERE WAS A BURNING SMELL. UPON INSPECTION, TWO SCREWS ON TWO SOLID-STATE RELAYS WERE LOOSE, WITH ONE OF THEM CAUSING SPARKS AND A BURNING SMELL, DANGEROUSLY CLOSE TO ELECTRICAL WIRING. SERVICE TEAM TIGHTENED THE SCREWS AND UNIT IS FUNCTIONING PROPERLY. NO HARM OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269004 K-SYSTEMS LAMINAR AIRFLOW HOOD PUB COOPERSURGICAL, INC. 6.131.812.121 N/A 00888937023985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown