BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6071713 · Received November 1, 2016

    Report

    Report Number
    8020030-2016-00053
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 8, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THE "OVERNIGHT ULTRAS" PROTOCOL STARTED IN RETORT A AT 17:35 ON (B)(6) 2016, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. NO USE ERROR(S) WAS IDENTIFIED IN THE INTERACTION BETWEEN THE USER AND THE INSTRUMENT EITHER PRIOR TO, OR DURING, EXECUTION OF THE "OVERNIGHT ULTRAS" PROTOCOL STARTED IN RETORT A AT 17:35 ON (B)(6) 2016, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED FROM THE "OVERNIGHT ULTRAS" PROTOCOL STARTED IN RETORT A AT 17:35 ON (B)(6) 2016 COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE QUALITY OF TISSUE PROCESSING FOR 60 OF 81 CASSETTES PROCESSED USING THE "OVERNIGHT ULTRAS" PROTOCOL, WHICH STARTED IN RETORT A ON (B)(6) 2016 AND COMPLETED ON (B)(6) 2016, WAS SUB-OPTIMAL. THE COMPLAINANT DESCRIBED THE AFFECTED TISSUE SAMPLES AS OVER-PROCESSED; AND REPORTED THAT THE QUALITY OF TISSUE PROCESSING FOR CASSETTES LOCATED IN THE TOP BASKET WAS SATISFACTORY AND THE AFFECTED TISSUE SAMPLES WERE LOCATED IN CASSETTES POSITIONED IN THE BOTTOM TWO (2) BASKETS. ON 13 SEPTEMBER 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT TISSUE FROM 24 PATIENTS HAD BEEN ADVERSELY AFFECTED; AND RE-BIOPSY HAD BEEN SCHEDULED FOR FOUR (4) OF THESE PATIENTS. AN IDENTIFIER; AGE OR DATE OF BIRTH AND GENDER OF EACH PATIENT SCHEDULED FOR RE-BIOPSY WAS SOUGHT. ON 16 SEPTEMBER 2016, LEICA BIOSYSTEMS RECEIVED FURTHER INFORMATION FROM THE COMPLAINANT THAT EIGHT (8) PATIENTS REQUIRED RE-BIOPSY. ONE (1) OF THE EIGHT (8) PATIENT REQUIRED UPPER AND LOWER GASTRO INTESTINAL RE-BIOPSY. THE YEAR OF THE BIRTH AND GENDER OF EACH PATIENT REQUIRING RE-BIOPSY WAS PROVIDED. REFER TO MFR #8020030-2016-00054; #8020030-2016-00055; #8020030- 2016-00056; # 8020030-2016-00057; #8020030-2016-00058; #8020030-2016-00059; AND #8020030-2016-00060 FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721419 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention