BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSL 120

    MDR report key: 25324152 · Received May 28, 2026

    Report

    Report Number
    1419341-2026-00008
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 28, 2026
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    PSY
    UDI-DI
    00849832003762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE FOR THE ¿GSL-120 CRASHED BREAKING A SLIDE¿ COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. AN INSTRUMENT CRASH AND INCORRECT SLIDE LOADING MAY HAVE CAUSED THE SLIDE BREAKING REPORTED BY THE CUSTOMER. THE LEICA FIELD SERVICE TECHNICAL SPECIALIST DOCUMENTED AFTER REPAIRS WERE CARRIED OUT ON THE INSTRUMENT, THE INSTRUMENT RETURNED TO NORMAL FUNCTIONALITY.

    Description of Event or Problem · 0

    ON 30 APRIL 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND DOCUMENTED ¿GSL-120 CRASHED BREAKING A SLIDE¿. ON 13 MAY 2026, THE LEICA FIELD TECHNICAL SPECIALIST DOCUMENTED ¿ONLY ONE SLIDE BROKEN, ONE PATIENT AFFECTED. DID NOT HINDER TESTING RESULTS. THERE WERE SUFFICIENT REDUNDANT SLIDES MADE FROM THIS SAMPLE AND CULTURE(S).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227248 GSL 120 WHOLE SLIDE IMAGING SYSTEM PSY LEICA BIOSYSTEMS RICHMOND INC. GSL 120 00849832003762

    Patients

    Seq Age Sex Outcome Treatment
    1