BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP BIOPSY CASSETTE II, TAPED, PINK

    MDR report key: 23491128 · Received November 6, 2025

    Report

    Report Number
    1419341-2025-00038
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 6, 2025
    Manufacturer
    SIMPORT
    Product Code
    IDZ
    UDI-DI
    20849832022095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED IP BIOPSY CASSETTE II, TAPED, PINK, P/N: 38440501, LOT: 9178512530, WHERE THE FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. TRENDING ANALYSIS FROM 17 OCT 2024 TO 17 OCT 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE ROOT CAUSE FOR THE "FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 13 OCTOBER 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "ON-SITE WITH CUSTOMER ON (B)(6) 2025. MANAGER [NAME] INFORMED ME OF ISSUE WITH 38440501: IP BIOPSY CASSETTE II, TAPED, PINK. FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. ISSUE HAS OCCURRED ALL WEEK WHERE TISSUE IS BEING LOST. PER [NAME], THIS HAS OCCURRED WITH 3 DIFFERENT PAS EVEN AFTER PARTICULAR CARE IS BEING TAKEN. PAS FEEL THAT CASSETTES SEEM "SOFTER" AND MORE FRAGILE THAN PREVIOUSLY. SWITCHED TO NEW LOT# AND TAKING EXTRA PRECAUTIONS. THIS SITE IS ALSO USING THE SAME CASSETTE IN GREEN AND YELLOW, NO REPORTED ISSUES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702586 IP BIOPSY CASSETTE II, TAPED, PINK CASSETTES, TISSUE IDZ SIMPORT IP BIOPSY CASSETTE II, TAPED, PINK 9178512530 20849832022095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown