BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6199589 · Received December 22, 2016

    Report

    Report Number
    1423337-2016-00032
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT BIOPSY SAMPLES FROM A TISSUE PROCESSING RUN WERE UNDER-PROCESSED. ON 13 DECEMBER 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT RE-BIOPSY OF TWO (2) MALE PATIENTS WILL BE REQUIRED. IT WAS ALSO DOCUMENTED THAT THE INSTITUTION WAS NOT PREPARED TO PROVIDE ANY FURTHER PATIENT DETAILS. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. REFER TO IMPORTER REPORT NUMBERS 1423337-2016-00032 AND 1423337-2016-00033 FOR ALL PATIENTS INVOLVED.

    Description of Event or Problem · 1

    FOLLOWING THE LEICA BIOSYSTEMS MANUFACTURER'S INVESTIGATION OF THIS COMPLAINT, IT WAS FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR. SPECIFICALLY, A USER FAILED TO COMPLETE MANUAL REPLACEMENT OF A REAGENT IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS LL USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARNING: "ALWAYS CHANGE REAGENTS WHEN PROMPTED. ALWAYS UPDATE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT REPLACING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS." SEE MANUFACTURER FOLLOW UP REPORTS 8020030-2016-00090 AND 8020030-2016-00091 FOR MORE SPECIFIC INFORMATION REGARDING THE INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848196 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other