BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IP ROUTINE VI TAPED, GREEN 1000

    MDR report key: 11925256 · Received June 2, 2021

    Report

    Report Number
    1419341-2021-00001
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 12, 2023
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    IDZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETAIN SAMPLE ANALYSIS WAS COMPLETED. THE RETAIN CASSETTES ARE OF NORMAL APPEARANCE AND THE LIDS ALL SNAPPED AND REMAINED CLOSED. THE LIDS DID NOT OPEN OR SNAP CLOSED WITHOUT THE APPLICATION OF FORCE, AS EXPECTED. ALL THE CASSETTES WERE RAN ON THE LEICA PELORIS TISSUE PROCESSOR. UPON COMPLETION OF TISSUE PROCESSING, THE CASSETTES WERE FOUND TO HAVE REMAINED CLOSED AND THERE WERE NO CRACKS OR DISTURBANCES TO THE PLASTIC. ALL THE CASSETTES DEMONSTRATED AN AUDIBLE SNAP WHEN OPENED, INDICATING THE CLOSURE WAS NOT DAMAGED DURING PROCESSING. THE BOTTOM PART OF THE LIDS WERE ALL ATTACHED TO THE BASE OF THE CASSETTES. THE REPORTED ISSUE OF THE IP ROUTINE VI TAPED, GREEN 1000, P/N 39LC-550-4-L, LOT 201911035 OPENING CAUSING TISSUE LOSS WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D3 WAS CORRECTED TO INCLUDE THE MANUFACTURING ADDRESS. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. THE PRODUCT POSES A BIO-HAZARD CONCERN TO HAVE IT RETURNED FOR FURTHER TESTING BY THE MANUFACTURER DUE TO THE EXPOSURE OF TISSUE, THEREFORE ADDITIONAL TESTING ON THE CUSTOMER'S SLIDE CANNOT BE COMPLETED. RETAINS ARE AVAILABLE AND ADDITIONAL TESTING WILL BE COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER EXPERIENCED ONE (1) CASSETTE OF THE IP ROUTINE VI TAPED, GREEN 1000 (P/N 39LC-550-4-L, LOT 201911035), WHICH HAD OPENED DURING PROCESSING CAUSING TISSUE LOSS THAT REQUIRED RE-BIOPSY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815003 IP ROUTINE VI TAPED, GREEN 1000 IP ROUTINE VI TAPED, GREEN 1000 IDZ LEICA BIOSYSTEMS NA 201911035

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Other