BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE BOND APEX ADHESIVE

    MDR report key: 24139693 · Received January 21, 2026

    Report

    Report Number
    1419341-2026-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    October 30, 2025
    Report Date
    January 21, 2026
    Manufacturer
    KNITTEL GLASER
    Product Code
    KEW
    UDI-DI
    20849832016438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED TISSUE WOULD NOT STAY ON THE SLIDE BOND APEX ADHESIVE, P/N 3800040, LOT 4900076974. TRENDING ANALYSIS FROM 11 DEC 2024 TO 11 DEC 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. RETAIN SAMPLES WERE UNAVAILABLE TO THE MANUFACTURER FOR TESTING. INFORMATION PROVIDED BY THE CUSTOMER DETAILED ALL AVAILABLE SAMPLES AT THE CUSTOMER SITE WERE EITHER USED IN FULL OR DISPOSED OF. AS A RESULT, LEICA BIOSYSTEMS WAS UNABLE TO TEST SAMPLES. THE ROOT CAUSE FOR THE "TISSUE FLOATS AWAY" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IN THE CONTEXT OF TISSUE ANALYSIS, THE LOSS OF TISSUE IS DEEMED RECOVERABLE WITHOUT THE NEED FOR RE-BIOPSY. THIS IS BECAUSE THE AMOUNT OF TISSUE REQUIRED FOR ANALYSIS IS OFTEN VERY SMALL AND A PORTION OF THE INITIAL SAMPLE WOULD HAVE BEEN PRESERVED FOR FURTHER TESTING. THEREFORE, IN SITUATIONS WHERE A SMALL AMOUNT OF TISSUE IS LOST DURING ANALYSIS, IT IS GENERALLY CONSIDERED RECOVERABLE WITHOUT THE NEED FOR FURTHER BIOPSY. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 21 NOVEMBER 2025, A COMPLAINT WAS RAISED WITH THE FOLLOWING INFORMATION "CUSTOMER USED APEX BOND FOR IHC STAINING ON BOND III AND BOND PRIME AND NOTICED THAT OFTEN TISSUE FLOATS AWAY, THE SWITCHED TO XTRA WITH MUCH BETTER PERFORMANCE."ON 15 DECEMBER 2025, THE LEICA ACCOUNT MANAGER ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 30 OCTOBER 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200394 SLIDE BOND APEX ADHESIVE SLIDES, MICROSCOPE KEW KNITTEL GLASER SLIDE BOND APEX ADHESIVE 4900076974 20849832016438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown