BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP BIOPSY CASSETTE II, TAPED, GREEN

    MDR report key: 23873393 · Received December 22, 2025

    Report

    Report Number
    1419341-2025-00039
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    May 15, 2025
    Report Date
    December 23, 2025
    Manufacturer
    SIMPORT SCIENTIFICQUE INC.
    Product Code
    IDZ
    UDI-DI
    20849832022101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETAIN SAMPLES WERE NOT AVAILABLE FOR FURTHER TESTING. THE ROOT CAUSE FOR "BIOPSY CASSETTE II TABS BROKEN" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. TRENDING ANALYSIS FROM 10 DEC 2024 TO 10 DEC 2025 REPORTED ONE (1) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 03 DECEMBER 2025, LEICA BIOSYSTEMS WAS MADE AWARE OF AN INCIDENT REPORTED TO HEALTH CANADA BY THE CUSTOMER. THE CUSTOMER PROVIDED THE FOLLOWING DETAILS: "AT EMBEDDING OF OUTPATIENT¿S TISSUE SPECIMEN IN HISTOLOGY DEPARTMENT, THERE SHOULD HAVE BEEN TWO PIECES OF TISSUE IN THE CASSETTE, BUT CASSETTE WAS FOUND EMPTY. INTERNAL TAB ON CASSETTE WAS OBSERVED TO BE BROKEN. GROSSING BASKET WAS EMPTY. ONE PIECE WAS FOUND IN THE PROCESSOR RETORT; THE SECOND PIECE WAS LOST. THE FOUND PIECE OF TISSUE WAS EMBEDDED IN BLOCK X AND THREE LEVELS WERE CUT AND STAINED WITH HEMATOXYLIN AND EOSIN; PATHOLOGIST REVIEWED AND CONFIRMED IT WAS THE CORRECT TISSUE TYPE. SLIDE WAS LABELED AS PART C. BLOCK X WAS MELTED AND TISSUE RE-EMBEDDED IN PART C CASSETTE. (TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN.)" ON 03 DECEMBER 2025, THE FOLLOWING INFORMATION WAS DOCUMENTED: "TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328969 IP BIOPSY CASSETTE II, TAPED, GREEN CASSETTES, TISSUE IDZ SIMPORT SCIENTIFICQUE INC. IP BIOPSY CASSETTE II, TAPED, GREEN 9309405604 20849832022101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown