BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6126707 · Received November 23, 2016

    Report

    Report Number
    8020030-2016-00077
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26 JANUARY 2017, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION IN WRITTEN COMMUNICATION FROM THE QUALITY MANAGER AND HEAD OF DEPARTMENT HISTOPATHOLOGY AT THE INSTITUTION: "...WE WOULD LIKE TO EXPRESS OUR DISAPPOINTMENT ON THE REPORTED FINDINGS, PARTICULARLY IN REGARDS TO THE QUOTE "...THE CUSTOMER AGREES THAT THEY THINK AN INCORRECT REAGENT WAS PUT ON THE INSTRUMENT' WE DO NOT RECALL AT ANY OCCASION WE MADE SUCH A STATEMENT." THE WRITTEN COMMUNICATION ALSO INCLUDED THE FOLLOWING NEW INFORMATION: "TISSUE PROCESSING ISSUE WAS FIRST REPORTED ON (B)(6) 2016 FRIDAY WHEN IN THE MORNING THE SAMPLES COMING OUT OF WAX SMELT OF ALCOHOL. THE SAME DAY A FEW CASES PROCESSED ON (B)(6) WERE ALSO RETURNED FROM PATHOLOGIST WITH PROCESSING PROBLEMS. THIS HAS BEEN CAUGHT DURING QA REPORTING." THE CLARIFYING INFORMATION PROVIDED BY THE INSTITUTION IN THE WRITTEN COMMUNICATION INDICATES THAT A USE ERROR DID NOT OCCUR PRIOR TO COMMENCEMENT OF THE "ROUTINE OVERNIGHT 45" PROTOCOL STARTED IN RETORT A AT 16:57PM ON (B)(6) 2016, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED IN THE COMPLAINT RECEIVED BY LEICA BIOSYSTEMS ON (B)(6) 2016; AND AS A CONSEQUENCE, THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED FROM THE "ROUTINE OVERNIGHT 45" PROTOCOL STARTED IN RETORT A AT 16:57PM ON (B)(6) 2016 COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. INVESTIGATION OF THE ADDITIONAL INFORMATION PROVIDED REGARDING "PROCESSING PROBLEMS" INVOLVING CASES PROCESSED ON (B)(6) 2016 FOUND THAT TWO (2) PROCESSING RUNS EITHER STARTED OR COMPLETED ON THIS DATE. SPECIFICALLY, THE "ROUTINE OVERNIGHT 45" PROTOCOL WHICH STARTED IN RETORT A AT 16:35PM ON (B)(6) 2016 AND COMPLETED AT 07:00AM ON (B)(6) 2016; AND THE "ROUTINE OVERNIGHT 45" PROTOCOL WHICH STARTED IN RETORT A AT 16:59PM ON (B)(6) 2016 AND COMPLETED ON (B)(6) 2016. EVALUATION OF THE INSTRUMENT LOGS FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THESE TWO (2) PROTOCOLS; AND THERE WAS NO EVIDENCE OF A USER INTERACTION WITH THE INSTRUMENT THAT WOULD HAVE ADVERSELY IMPACTED THE QUALITY OF THE TISSUE PROCESSING FROM THESE TWO (2) PROTOCOLS. THE ROOT CAUSE OF THE "PROCESSING PROBLEMS" REPORTED FROM "ROUTINE OVERNIGHT 45" PROTOCOLS WHICH STARTED IN RETORT A AT 16:35PM ON (B)(6) 2016 AND 16:59PM ON (B)(6) 2016 COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT FOUND THAT THE REAGENT IN BOTTLES 4 (ETHANOL) AND 13 (XYLENE) AND THE WAX IN WAX CHAMBER 4 HAD BEEN REPLACED IN THE PERIOD PRIOR TO COMMENCEMENT OF THE "ROUTINE OVERNIGHT 45" PROTOCOL STARTED IN RETORT A AT 16:57PM ON (B)(6) 2016, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. THE REAGENT IN BOTTLES 4 (ETHANOL) AND 13 (XYLENE) WAS USED FOR THE FINAL DEHYDRATION AND CLEARING STEPS RESPECTIVELY OF THE "ROUTINE OVERNIGHT 45" PROTOCOL STARTED IN RETORT A AT 16:57PM ON (B)(6) 2016. THE INSTRUMENT WAS FOUND TO HAVE FUNCTIONED AS DESIGNED DURING EXECUTION OF THIS PROTOCOL. BASED ON INFORMATION REPORTED BY A LEICA FIELD SUPPORT SPECIALIST THAT: "..THE CUSTOMER AGREES THAT THEY THINK AN INCORRECT REAGENT WAS PUT ON THE INSTRUMENT" DETERMINED THAT THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT WAS A USE ERROR, WHICH OCCURRED PRIOR TO COMMENCEMENT OF THE "ROUTINE OVERNIGHT 45" PROTOCOL STARTED IN RETORT A AT 16:57PM ON (B)(6) 2016. AS THE REAGENTS ON THE INSTRUMENT AT THE TIME OF THE EVENT HAD BEEN DISCARDED PRIOR TO ATTENDANCE AT THE LABORATORY BY A LEICA REPRESENTATIVE, IT WAS NOT POSSIBLE TO EITHER MEASURE THE ETHANOL CONCENTRATION IN BOTTLES DESIGNED FOR THIS REAGENT OR TO PERFORM CHEMICAL ANALYSIS OF THE REAGENT IN BOTTLES DESIGNATED FOR XYLENE. AS A CONSEQUENCE, IT IS NOT POSSIBLE TO ESTABLISH WHETHER THE USE ERROR OCCURRED DURING REPLACEMENT OF THE REAGENT IN EITHER BOTTLE 4 (ETHANOL) OR 13 (XYLENE). THE MANUFACTURER INSTRUCTIONS FOR MANUAL REAGENT REPLACEMENT ARE DETAILED IN SECTION 5.4.4 OF THE LEICA PELORIS/PELORIS LL USER MANUAL; AND CONTAIN THE FOLLOWING 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."

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING POOR PROCESSING OF TISSUE SAMPLES FROM A PROCESSING RUN IN RETORT A, WHICH COMPLETED ON (B)(6) 2016. THE COMPLAINANT REPORTED THAT 150 BLOCKS OF TISSUE MAY HAVE BEEN ADVERSELY AFFECTED; THE TISSUE SAMPLES SMELT OF ALCOHOL AND HAD NOT BEEN PROCESSED. ON 31 OCTOBER 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION FROM A LEICA FIELD SUPPORT SPECIALIST (FSS) THAT TISSUE IN FIVE (5) BLOCKS FROM THREE (3) CASES WAS NOT DIAGNOSABLE AND RE-BIOPSY HAD BEEN ADVISED (THIS INFORMATION WAS RECEIVED BY LEICA BIOSYSTEMS (B)(4) ON 01 NOVEMBER 2016). THE FSS ALSO REPORTED THAT: "..THE CUSTOMER AGREES THAT THEY THINK AN INCORRECT REAGENT WAS PUT ON THE INSTRUMENT." AN IDENTIFIER, THE AGE OR DATE BIRTH AND THE GENDER OF EACH PATIENT WAS REQUESTED. ON 07 NOVEMBER 2016, LEICA BIOSYSTEMS (B)(4) RECEIVED INFORMATION THAT RE-BIOPSY OF TWO (2) PATIENTS WAS REQUIRED. THE DATE OF BIRTH AND GENDER OF EACH PATIENT WERE ALSO PROVIDED. REFER TO MFR. REPORT# 8020030-2015-00076 FOR SPECIFIC DETAILS OF THE OTHER PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777049 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR