BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX TS-10

    MDR report key: 23832123 · Received December 17, 2025

    Report

    Report Number
    1000515253-2025-00007
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 17, 2025
    Manufacturer
    SYSMEX RA CO.,LTD. MAIN PLANT
    Product Code
    LXG
    UDI-DI
    049875624331552
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSMEX AMERICA, INC. (SAI) RECEIVED A REPORT OF A HAND INJURY SUSTAINED BY AN OPERATOR WHILE MANUALLY REMOVING A JAMMED RACK FROM THE CARRY-IN LINE OF THE TS-10 AUTOMATED TUBE SORTER. THE CUSTOMER REPORTED A FINGER INJURY WHILE ATTEMPTING TO TROUBLESHOOT RACKS THAT WERE JAMMING ON THE TS-10. THE CUSTOMER REPORTED TO EMPLOYEE HEALTH WHERE THE LACERATION WAS CLEANED AND BANDAGED. NO ADDITIONAL TREATMENT OR SERIOUS INJURY WAS REPORTED. THE INCIDENT OCCURRED WHEN THE OPERATOR ATTEMPTED TO CLEAR THE RACK JAM FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTION 5.7. DURING THIS PROCESS, THE LIFT'S MAGNETIC HOLDING FORCE WAS UNEXPECTEDLY RELEASED, CAUSING THE LIFT TO DROP SUDDENLY AND THE OPERATOR'S HAND TO BECOME CAUGHT BETWEEN MOVING PARTS. THE LEGAL MANUFACTURER, SYSMEX CORPORATION - JAPAN (S-CORP), PERFORMED AN INTERNAL INVESTIGATION WHICH CONFIRMED THAT, UNDER SPECIFIC CONDITIONS, THE LIFT'S ELECTROMAGNETIC HOLDING FORCE MAY DISENGAGE UNEXPECTEDLY, ALLOWING UNINTENDED DOWNWARD MOVEMENT OF THE LIFT. S-CORP CONFIRMED THIS EVENT MAY OCCUR DURING THE PROCEDURE DESCRIBED IN THE TS-10 IFU, CHAPTER 5.7- "REMOVING A RACK OR FOREIGN OBJECT FROM THE CARRY-IN LINE". A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS INITIATED ON 12/4/2025 BY THE MANUFACTURER, S-CORP. THE COUNTERMEASURES ARE TO ALERT THE IMPACTED CUSTOMERS ABOUT THE RISK OF INJURY WHEN REMOVING RACKS VIA FIELD SAFETY NOTICE AND UPGRADE ALL DEVICES WITH SOFTWARE VERSION 00-17 OR EARLIER TO SOFTWARE VERSION 00-18 OR LATER. IN SOFTWARE VERSION 00-18, A FUNCTION WAS IMPLEMENTED THAT LOWERS THE LIFT TO THE BOTTOM DEAD POINT WHEN AN ERROR OCCURS IN THE LIFT SECTION WHICH MITIGATES THE RISK OF SERIOUS INJURY. HEALTH HAZARD EVALUATION (ATTACHMENT 1) DETERMINED THE OVERALL RISK RATING IS MEDIUM FOR THE WORST-CASE SCENARIO - USER'S FINGERS CAUGHT BY THE LIFT OF TS-10 RESULTING IN PARTIAL AMPUTATION. OVERALL PROBABILITY OF 1 AND A SEVERITY OF 4 WAS ASSIGNED. A CLASS 2 RECALL WILL BE INITIATED FOR THIS FSCA.

    Description of Event or Problem · 0

    A DEVICE MALFUNCTION WAS IDENTIFIED FOR THE AUTOMATED TUBE SORTER TS-10 WITH SOFTWARE VERSIONS PRIOR TO VER.00-18, WHERE, UNDER SPECIFIC CONDITIONS, THE LIFT'S ELECTROMAGNETIC HOLDING FORCE MAY DISENGAGE UNEXPECTEDLY, ALLOWING UNINTENDED DOWNWARD MOVEMENT OF THE LIFT. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039478 SYSMEX TS-10 AUTOMATED TUBE SORTER LXG SYSMEX RA CO.,LTD. MAIN PLANT 049875624331552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown