HistoCore PELORIS HistoCore PELORIS 3 (100-120V)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 09349458004811), received between Jun 6, 2022 and Sep 22, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 2, 2025Class IIOpen, Classified

   There is a leakage issue associated with the tubing in the manifold of the instrument.

   Z-1683-2025 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Improper or Incorrect Procedure or Method

  On 24 August 2026, the customer contacted Leica Biosystems and reported that ¿Tissue through Cleaning cycle. Tissues were left in the processor and went through the cleaning cycle, are there any recommendations for ways to mitigate the damage? The blocks are quite crispy.¿On 29 August 2026, the Leica Senior Applications Specialist documented ¿¿all 8 cases have been signed out, diagnosed. Customer also stated that if needed, they could go back to gross tissue for re-grossing for processing.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849963 ↗
• MalfunctionFeb 4, 2026Improper or Incorrect Procedure or Method

  ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED THAT ¿BIOPSIES PROCESSED THROUGH QUICK CLEAN PROTOCOL. REQUESTING REPROCESSING SUPPORT¿. ON 08 JANUARY 2026, THE LEICA SENIOR APPLICATIONS SPECIALIST CONFIRMED ¿THE QUICK CLEAN COMPLETED "SUCCESSFULLY", ALL THE WAY THROUGH THE DRY STEP.¿ ON 09 JANUARY 2026, THE LEICA SENIOR APPLICATIONS SPECIALIST DOCUMENTED "3 OF 4 CASES SIGNED OUT, 1 PENDING IHC (NOT DUE TO THIS EVENT). - PATIENT DIAGNOSIS NOT IMPACTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264307 ↗
• MalfunctionJan 13, 2026Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED SMALL BIOPSY SAMPLES WERE PLACED ON A 8-HOUR PROCESSING RUN WHICH RESULTED IN OVERPROCESSED SAMPLES. THE PATHOLOGIST STATED THE SAMPLES WERE "...DRY, NUCLEI ARE DARK, AND CRACKED. DIFFICULT TO DIAGNOSE." ON 22 DECEMBER 2025, THE LEICA FIELD APPLICATIONS SPECIALIST RECEIVED INFORMATION FROM THE CUSTOMER THAT PATIENT OUTCOME WAS UNKNOWN AS "WE DO NOT HAVE THAT INFORMATION ON HAND. OUR DOCTORS ARE NOT INFORMED ON THAT." ON (B)(6) 2025, THE LEICA FIELD APPLICATIONS SPECIALIST DOCUMENTED THAT ¿IT WAS DISCOVERED THAT THEIR ROUTINE WAS TO PROCESS ALL SAMPLES ON THE 8-HOUR XYLENE FREE OVERNIGHT EXCEPT FOR FATTY BREAST SAMPLES...THE PATHOLOGIST WAS GOING TO CREATE SOME PRACTICE SAMPLES THE SIZE OF THOSE THEY ARE CURRENTLY HAVING OVER PROCESSING ON AND TEST THOSE ON THE 2-HOUR PROCESSING PROTOCOL. I WENT OVER ALL THE FACTORY DEFAULT PROTOCOLS AND THE SIZE CHART IN THE QUICK TIPS GUIDE. I BELIEVE SOME MAY NEED TO BE ON THE 1HOUR PROTOCOL, BUT THE REDUCTION FROM 8 TO 2 HOURS SHOULD YIELD HIGHER QUALITY SPECIMENS.¿

  Patient problems: Insufficient Information

  MAUDE report 24062598 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEICA BIOSYSTEMS (LBS) RECEIVED A COMPLAINT OF UNDER PROCESSED TISSUE ON BOTH RETORTS AND 2 RUNS AFFECTED. ON (B)(6) 2025, THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE FOLLOWING INFORMATION, "THE TISSUE STATUS IS CURRENTLY NOT DIAGNOSABLE ON 1 AFFECTED CASE. THE REST OF THE CASES WERE ABLE TO BE DIAGNOSED. I HAVE INCLUDED DEMOGRAPHIC INFORMATION ON THE ADVERSE EVENT FORM. THE PATIENT TISSUE THAT IS NOT DIAGNOSABLE HAS BEEN RECOMMENDED FOR RE-BIOPSY; THE PROCEDURE HAS NOT BEEN PERFORMED YET..." PATIENT IDENTIFIER INFORMATION WAS PROVIDED FOR THE AFFECTED PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23804159 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED ¿UNDER PROCESS TISSUE BOTH RETORTS AND 2 RUNS AFFECTED TISSUE APPEARS TO BE UNDER PROCESS ALL BIOPSIES, NO ERROR PROMPTED, TISSUES APPEARS HAZY UNDER SCOPE. TISSUE BEEN FIX PRIOR TO PLACING IN THE PROCESSOR. NO REAGENT CHANGE PRIOR TO RUN. RUN TO COMPLETION.¿ INFORMATION PROVIDED BY THE LEICA FIELD APPLICATIONS SPECIALIST II (FAS) DETAILED ¿THE UNDER PROCESSED TISSUE WAS REPORTED AS INTERMITTENT, NOT ALL SPECIMENS ON THE AFFECTED RUNS WERE PROCESSED POORLY. THE AFFECTED PROGRAMS RAN TO COMPLETION WITH NO INSTRUMENT ERRORS. CHECKED ALL REAGENT STATIONS. THERE WAS NO CROSS-CONTAMINATION FOUND IN ANY OF THE STATIONS. FILL LEVELS FOR THE REAGENT STATIONS WERE APPROPRIATE EXCEPT FOR STATION 3, WHICH WAS OVER-FILLED. THE REAGENT BOTTLES WERE PROPERLY MAINTAINED, NO NOTED EXCESSIVE BUILD-UP IN THE BOTTLES.¿ THE FAS ¿CHANGED THE REAGENT CHANGE THRESHOLD FOR XYLENE FROM 80% TO 68%. REMOVED THE 1200 CASSETTE FINAL THRESHOLD FROM THE FORMALIN STATION. CHANGED THE ETHANOL FINAL REAGENT THRESHOLD FROM 99% TO 98% ACCORDING TO FACTORY RECOMMENDATIONS.¿ THE FAS ALSO DOCUMENTED ¿THE AFFECTED INSTRUMENT IS ONLY USED FOR BIOPSY TISS

  Patient problems: Insufficient Information

  MAUDE report 23764772 ↗
• InjuryDec 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 07 NOVEMBER 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: "OVER AND UNDER PROCESSED TISSUE OCCURRED DURING DAYTIME (B)(6) 2025. 5 RUNS WITH 75 CASES (MORE THAN ONE CASSETTE / CASE). ACROSS 4 PELORIS PROCESSORS, USER APPARENTLY RAN TISSUES ON INCORRECT PROGRAMS. TISSUE WAS EITHER UNDER PROCESSED, OR VERY OVER PROCESSED. OVER PROCESSED TISSUE REHYDRATED WITH SOFTENING AGENTS SOME TISSUE RECOVERED, SOME TISSUE NOT RECOVERED, AFFECTED PATIENTS HAVE BEEN NOTIFIED." ON 02 DECEMBER 2025, THE LEICA FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AT LEAST ONE PATIENT COULD NOT BE DIAGNOSED AND THE CUSTOMER IS UNWILLING TO PROVIDE PATIENT IDENTIFIERS FOR THE AFFECTED PATIENT TISSUE SAMPLE(S) - THE EXACT NUMBER OF CASES IS UNKNOWN. THE ADDITIONAL INSTRUMENTS INVOLVED IN THIS EVENT ARE DOCUMENTED IN 3022446399-2025-00012, 3022446399-2025-00014 AND 3022446399-2025-00015.

  Patient problems: Insufficient Information

  MAUDE report 23716085 ↗
• InjuryDec 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 07 NOVEMBER 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: "OVER AND UNDER PROCESSED TISSUE OCCURRED DURING DAYTIME MON. (B)(6) 2025. 5 RUNS WITH 75 CASES ( MORE THAN ONE CASSETTE / CASE) ACROSS 4 PELORIS PROCESSORS, USER APPARENTLY RAN TISSUES ON INCORRECT PROGRAMS. TISSUE WAS EITHER UNDER PROCESSED, OR VERY OVER PROCESSED. OVER PROCESSED TISSUE REHYDRATED WITH SOFTENING AGENTS SOME TISSUE RECOVERED, SOME TISSUE NOT RECOVERED, AFFECTED PATIENTS HAVE BEEN NOTIFIED." ON 02 DECEMBER 2025, THE LEICA FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AT LEAST ONE PATIENT COULD NOT BE DIAGNOSED AND THE CUSTOMER IS UNWILLING TO PROVIDE PATIENT IDENTIFIERS FOR THE AFFECTED PATIENT TISSUE SAMPLE(S) - THE EXACT NUMBER OF CASES IS UNKNOWN. THE ADDITIONAL INSTRUMENTS INVOLVED IN THIS EVENT ARE DOCUMENTED IN 3022446399-2025-00013, 3022446399-2025-00014 AND 3022446399-2025-00015.

  Patient problems: Insufficient Information

  MAUDE report 23716084 ↗
• InjuryDec 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 07 NOVEMBER 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: "OVER AND UNDER PROCESSED TISSUE OCCURRED DURING DAYTIME MON. (B)(6), 2025 5 RUNS WITH 75 CASES ( MORE THAN ONE CASSETTE / CASE) ACROSS 4 PELORIS PROCESSORS, USER APPARENTLY RAN TISSUES ON INCORRECT PROGRAMS. TISSUE WAS EITHER UNDER PROCESSED, OR VERY OVER PROCESSED. OVER PROCESSED TISSUE REHYDRATED WITH SOFTENING AGENTS SOME TISSUE RECOVERED , SOME TISSUE NOT RECOVERED, AFFECTED PATIENTS HAVE BEEN NOTIFIED." ON 02 DECEMBER 2025, THE LEICA FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, MID-ATLANTIC PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AT LEAST ONE PATIENT COULD NOT BE DIAGNOSED AND THE CUSTOMER IS UNWILLING TO PROVIDE PATIENT IDENTIFIERS FOR THE AFFECTED PATIENT TISSUE SAMPLE(S) ¿ THE EXACT NUMBER OF CASES IS UNKNOWN. REPORT 8020030-2025-00072, 8020030-2025-00073, 8020030-2025-00074 AND 8020030-2025-00075 ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23709454 ↗
• InjuryDec 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: "OVER AND UNDER PROCESSED TISSUE OCCURRED DURING DAYTIME MON. (B)(6) 2025 5 RUNS WITH 75 CASES ( MORE THAN ONE CASSETTE / CASE). ACROSS 4 PELORIS PROCESSORS, USER APPARENTLY RAN TISSUES ON INCORRECT PROGRAMS. TISSUE WAS EITHER UNDER PROCESSED, OR VERY OVER PROCESSED. OVER PROCESSED TISSUE REHYDRATED WITH SOFTENING AGENTS SOME TISSUE RECOVERED , SOME TISSUE NOT RECOVERED, AFFECTED PATIENTS HAVE BEEN NOTIFIED." ON 02 DECEMBER 2025, THE LEICA FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, MID-ATLANTIC PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AT LEAST ONE PATIENT COULD NOT BE DIAGNOSED AND THE CUSTOMER IS UNWILLING TO PROVIDE PATIENT IDENTIFIERS FOR THE AFFECTED PATIENT TISSUE SAMPLE(S) ¿ THE EXACT NUMBER OF CASES IS UNKNOWN. REPORT: 8020030-2025-00073, 8020030-2025-00074 AND 8020030-2025-00075 ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23709337 ↗
• InjurySep 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: ¿DEVIATION IN THE QUALITY OF PROCESSED SAMPLES.¿ ON (B)(6) 2025, THE LEICA SR. FIELD APPLICATIONS SPECIALIST - ADVANCED STAINING & IMAGING PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿THE CUSTOMER CONTACTED US ON (B)(6), REPORTING THAT ALL SAMPLES PROCESSED BETWEEN (B)(6) SHOWED QUALITY DEVIATIONS (APPROXIMATELY 1,343 BLOCKS). THE EXACT NUMBER AND STATUS OF THE SAMPLES HAVE NOT YET BEEN CONFIRMED, BUT THE CUSTOMER STATES THAT SEVERAL SAMPLES WILL REQUIRE REPROCESSING AND SOME WILL POSSIBLY REQUIRE A NEW PATIENT SAMPLE. THE CUSTOMER STATES THAT ON (B)(6), THEY NOTICED THAT BOTTLES 10 (ABSOLUTE ALCOHOL) AND 12 (XYLENE) WERE INVERTED. ON (B)(6), THE CUSTOMER REPLACED BOTTLES 10, 11, AND 12, AND ACCORDING TO THE CUSTOMER, PROCESSING RETURNED TO NORMAL (SAMPLES WERE CUT AND STAINED BUT HAVE NOT YET BEEN EVALUATED BY PATHOLOGISTS). ON (B)(6), LEICA PERFORMED PREVENTIVE MAINTENANCE ON THE EQUIPMENT¿QUESTIONS WHETHER THE BOTTLE REPLACEMENT COULD HAVE BEEN PERFORMED DURING THE PREVENTIVE MAINTENANCE SINCE THEY CLAIM THEY DID NOT PERFORM ANY REAGENT REPLACEMENTS DURING THIS PERIOD.¿ ON (B)(6) 2025, THE LEICA SR. FIELD AP

  Patient problems: Insufficient Information

  MAUDE report 23092028 ↗
• MalfunctionAug 7, 2025Leak/Splash; Leak/Splash

  ON (B)(6) 2025, THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: ¿LEAKING FORMALING [SIC] SINCE PM WAS PERFORMED. THE LEAK IS ABOUT AN INCH IN THE DRIP TRAY. FORMALIN BOTTLES, CONNECTORS, AND O- RINGS CHECKED AND THEY LOOK FINE. I PULLED THE PROCESSOR OUT TO STRIP AND WAX THE FLOORS THIS WEEKEND AND THE DRIP PAN WAS FULL OF FORMALIN AND BUFFERING SALTS. THE LEAK IS ABOUT ¾ CUP EVERY TWO DAYS. AT THE END OF THE FORMALIN¿S LIFE, IT IS AT THE 2 BASKET MINIMUM LINE (SO, ABOUT 2.5 LITERS LOW).¿ ON (B)(6) 2025, THE CUSTOMER REPORTED THAT ¿I HAVE HAD EMPLOYEES COMPLAIN TO ME ABOUT THE SMELL AND THEIR EYES WATERING.¿ NO LOST TIME AT WORK I.E. SICK LEAVE, MEDICAL TREATMENT, OR ADVERSE CONSEQUENCE(S) TO A STAFF MEMBER(S) OR PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER. ON (B)(6) 2025, THE ASSIGNED LEICA FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, MID-ATLANTIC (FAS) VISITED THE CUSTOMER AND DOCUMENTED THE AMOUNT OF LEAKED FORMALIN WAS ESTIMATED TO BE ABOUT AN INCH IN THE TRAY. INVESTIGATION OF THE INSTRUMENT FOUND THE FORMALIN BOTTLES, CONNECTORS, AND O-RINGS APPEARED INTACT WITH NO VISIBLE DAMAGE. A FORMALIN LEVEL TEST WAS PERFORMED, AND THE EXPOSURE LEVEL WAS FOUND TO BE ELEVATED. O

  Patient problems: Eye Irritation

  MAUDE report 22735045 ↗
• InjuryJul 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LEICA BIOSYSTEMS RECEIVED A COMPLAINT OF POOR PROCESSING. ON (B)(6) 2025, THE CUSTOMER INFORMED THE LEICA FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT THAT, "ONE CASE UNDIAGNOSABLE ON IMMUNOHISTOCHEMISTRY STAINS...RE-BIOPSY RECOMMENDED FOR THIS LYMPH NODE BIOPSY CASE."

  Patient problems: Insufficient Information

  MAUDE report 22660806 ↗
• InjuryJul 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 02 JULY 2025, THE CUSTOMER REPORTED THE FOLLOWING: ¿POOR PROCESSING, ISSUE FOR ABOUT 2-3 DAYS GROSSLY CONTAMINATED BOTTLES IN BOTH PELORIS 3 (B)(6), REAGENTS HAVE NOT RECENTLY BEEN CHANGED (I.E. 85% REAGENT, HIGHER AND LOWER CONCENTRATIONS UNAFFECTED). POTENTIALLY FAULTY ROTARY VALVE O RINGS?¿ THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿¿THE BOTTLE OF ALCOHOL IS CONTAMINATED WITH AN UNKNOWN REAGENT THAT IS NOT XYLENE AS IT WAS REPORTED EARLIER.¿ ON 03 JULY 2025, THE CUSTOMER INFORMED THE LEICA FIELD APPLICATION SPECIALIST, CORE HISTOLOGY THAT ¿ONE CASE UNDIAGNOSABLE ON IMMUNOHISTOCHEMISTRY STAINS¿.RE-BIOPSY RECOMMENDED FOR THIS LYMPH NODE BIOPSY CASE.¿ ON (B)(6) 2025, THE ASSIGNED LEICA FIELD APPLICATION SPECIALIST, CORE HISTOLOGY (FAS) VISITED THE CUSTOMER SITE TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT AND DOCUMENTED THE FOLLOWING: ¿CASSETTES ADDED DURING THE PROTOCOL. BOTTLES REMOVED WHILE PROTOCOL WAS RUNNING. DENSITY METER LOCKED BOTTLE. CUSTOMER MAKES THEIR OWN DILUTIONS OF 70,85,95. THEY CHANGE THE REAGENTS TO REFLECT THE FOLLOWING: BOTTLES 5 AND 6 AT 85% AND 7 AND 8 AT 95%...[THIRD PARTY] PERFORMED PM ON INSTRUMENT¿¿ THE FAS DOCUMENTED THAT T

  Patient problems: Insufficient Information

  MAUDE report 22656034 ↗
• InjuryJun 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LEICA BIOSYSTEMS (LBS) RECEIVED A TISSUE PROCESSING COMPLAINT WITH TISSUE BIOPSIES IMPACTED. ON 29 MAY 2025, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT FOUR (4) PATIENTS REQUIRE SPECIMEN RE-BIOPSY AS DIAGNOSIS COULD NOT BE MADE. THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE CUSTOMER IS UNWILLING TO PROVIDE PATIENT IDENTIFIER INFORMATION FOR THE FOUR (4) PATIENTS WHERE SPECIMEN RE-BIOPSY WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 22342943 ↗
• InjuryJun 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING: ¿TISSUE IMPACT, BIOPSIES NO ERRORS PROMPTED¿. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿ISSUE OCCURRED MAY 23, 2.5 HOUR PROTOCOL RETORT B. 42 SPECIMENS IN RUN, ALL IMPACTED. RETORT A, LARGE SPECIMENS (NO IMPACT). CUSTOMER HAS 70% DESIGNATION IN BOTTLES #3 AND #4. STATIONS WERE WITHIN CUSTOMER SET THRESHOLDS, WHICH WERE MEASURED WITH A HYDROMETER WITH A DIFFERENCE OF ABOUT 2%. BOTTLES 5 AND 6 HAD A MILKY, ORANGE APPEARANCE. BOTTLE #5, 92% SW/95% HYDROMETER. BOTTLE #6 91% SW/96% HYDROMETER. SPECIMENS: "CRISPY, DRY AND BROWN" GETTING GAPS IN SECTIONS. RE-BIOPSY REQUESTED FOR 4 PATIENTS. ALL REAGENTS WERE CHANGED ON (B)(6) AFTER CUSTOMER'S INVESTIGATION.¿ ON 30 MAY 2025, THE LOCAL ASSIGNED LEICA FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, MID-ATLANTIC (FAS) DOCUMENTED THAT THE INSTRUMENT ¿¿WAS PROGRAMMED TO RUN BY STATION RATHER THAN BY REAGENT TYPE. AS A RESULT, THE PROTOCOL USED ETHANOL FROM A FIXED STATION SET TO 83%, EVEN THOUGH THE SYSTEM¿S FINAL ETHANOL THRESHOLD WAS CONFIGURED AT 98%. BECAUSE THE REAGENT SELECTION WAS BASED ON STATION INSTEAD OF CONCENTRATION, THE UNIT PROCEEDED WITH SUB-THRESHOLD ETHANOL, LI

  Patient problems: Insufficient Information

  MAUDE report 22333456 ↗
• InjuryOct 31, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LEICA BIOSYSTEMS RECEIVED A COMPLAINT OF OVERPROCESSED TISSUE. THE LEICA BIOSYSTEMS FIELD APPLICATIONS SPECIALIST (FAS), INVESTIGATING THIS EVENT WITH THE COMPLAINANT, PROVIDED THE FOLLOWING INFORMATION, "ON (B)(6) 2024, I WAS TOLD BY THE SUPERVISOR THAT THERE WAS AT LEAST ONE CASE THAT WAS MORE THAN LIKELY NOT GOING TO BE ABLE TO BE DIAGNOSED. IT WAS CONFIRMED ON (B)(6) 2024, THAT TWO CASES COULD NOT BE DIAGNOSED FOR SURE." THE FAS ALSO DOCUMENTED THAT RE-BIOPSY HAS BEEN RECOMMENDED. INFORMATION REGARDING BOTH THE PATIENT IDENTIFIERS AND THE ASSOCIATED PATIENT IMPACT/OUTCOME HAS NOT BEEN PROVIDED TO LEICA BIOSYSTEMS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THIS INFORMATION FROM THE COMPLAINANT; HOWEVER, AS OF (B)(6) 2024, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE PATIENT IDENTIFIERS OF THE PATIENT TISSUE SAMPLES INVOLVED IN THIS EVENT OR THE PATIENT IMPACT/OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20584855 ↗
• InjuryOct 29, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 02 OCTOBER 2024, THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION: ¿OVER PROCESSED TISSUE.¿. BETWEEN 07 OCTOBER 2024 AND 09 OCTOBER 2024, THE (B)(6) FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, AMERICAS (FAS) VISITED THE CUSTOMER¿S SITE AND MEASURED THE PURITY OF THE RECYCLED XYLENE FRESH FROM THE RECYCLER. THE NEWLY RECYCLED XYLENE HAD A MEASURED PURITY OF 95%, WHICH IS BELOW THE FINAL REAGENT THRESHOLD REQUIRED BY THE INSTRUMENT. THE PURITY OF THE XYLENE ON THE INSTRUMENT WAS MEASURED AND FOUND TO BE LOWER THAN THE INSTRUMENT SOFTWARE VALUES. THE FAS REPLACED THE CLEANING REAGENTS AND REMOVED ANY RESIDUAL RECYCLED XYLENE FROM THE INSTRUMENT BEFORE CLEANING ALL REAGENT BOTTLES AND REPLACING ALL REAGENTS. DEDICATED 70% ETHANOL REAGENTS WERE PLACED IN THE INSTRUMENT AND THE PROTOCOLS UPDATED TO REFLECT THE CHANGE. TEST RUNS WERE SUCCESSFULLY CONDUCTED USING THE UPDATED INSTRUMENT SETTINGS. ON 22 OCTOBER 2024, THE ASSIGNED (B)(6) FIELD APPLICATIONS SPECIALIST ¿ (B)(4) (FAS) CONFIRMED ¿THINGS ARE GOING MUCH BETTER. THEY ARE NO LONGER USING RECYCLED XYLENE ON THE PROCESSOR.¿. ON 23 OCTOBER 2024, THE (B)(6) RECEIVED INFORMATION FROM THE (B)(4) FIELD APPLICATIONS SPECIALIST ¿ (B)

  Patient problems: Insufficient Information

  MAUDE report 20563777 ↗
• InjuryOct 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2024, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: "CUSTOMER COMPLAINS OF FORMALIN FUME EXPOSURE, AND HAS HAD MEDICAL ATTENTION." ON (B)(6) 2024, THE ASSIGNED LEICA BIOSYSTEMS FIELD APPLICATIONS SPECIALIST (FAS) VISITED THE CUSTOMER AND DOCUMENTED THAT A USER INITIALLY LOADED PATIENT TISSUE SAMPLES INTO RETORT B AND STARTED A TISSUE PROCESSING PROTOCOL. THE USER THEN ABANDONED THE TISSUE PROCESSING PROTOCOL, DRAINED THE REAGENT FROM THE RETORT, AND MOVED THE PATIENT TISSUE SAMPLES TO RETORT A. THE USER CLOSED THE LID TO RETORT B, WHICH CONTAINED RESIDUAL FORMALIN, AND DID NOT EXECUTE A CLEANING PROTOCOL. THE AFFECTED STAFF MEMBER OPENED RETORT B AND WAS EXPOSED TO AN ABUNDANCE OF FORMALIN FUMES THAT HAD ACCUMULATED IN THE RETORT. APPROXIMATELY TWENTY (20) MINUTES AFTER EXPOSURE, THE AFFECTED STAFF MEMBER STARTED TO EXPERIENCE CLOUDINESS IN HER RIGHT EYE AND SOUGHT MEDICAL ATTENTION. AN OPHTHALMOLOGIST EXAMINED THE AFFECTED STAFF MEMBER AND DIAGNOSED HER WITH CHEMICAL CONJUNCTIVITIS DUE TO EXPOSURE TO FORMALIN FUMES. THE AFFECTED STAFF MEMBER MISSED APPROXIMATELY FIVE (5) HOURS OF WORK WHILST RECEIVING MEDICAL ATTENTION.

  Patient problems: Conjunctivitis

  MAUDE report 20528343 ↗
• InjuryOct 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2024, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: ¿CUSTOMER COMPLAINS OF FORMALIN FUME EXPOSURE, AND HAS HAD MEDICAL ATTENTION¿. ON 27 SEPTEMBER 2024, THE ASSIGNED LEICA FIELD APPLICATIONS SPECIALIST II ¿ CORE HISTOLOGY, NORTHWEST (FAS) VISITED THE CUSTOMER AND DOCUMENTED THAT A USER INITIALLY LOADED PATIENT TISSUE SAMPLES INTO RETORT B AND STARTED A TISSUE PROCESSING PROTOCOL. THE USER THEN ABANDONED THE TISSUE PROCESSING PROTOCOL, DRAINED THE REAGENT FROM THE RETORT, AND MOVED THE PATIENT TISSUE SAMPLES TO RETORT A. THE USER CLOSED THE LID TO RETORT B, WHICH CONTAINED RESIDUAL FORMALIN, AND DID NOT EXECUTE A CLEANING PROTOCOL. THE AFFECTED STAFF MEMBER OPENED RETORT B AND WAS EXPOSED TO AN ABUNDANCE OF FORMALIN FUMES THAT HAD ACCUMULATED IN THE RETORT. APPROXIMATELY TWENTY (20) MINUTES AFTER EXPOSURE, THE AFFECTED STAFF MEMBER STARTED TO EXPERIENCE CLOUDINESS IN HER RIGHT EYE SO SOUGHT MEDICAL ATTENTION. AN OPHTHALMOLOGIST EXAMINED THE AFFECTED STAFF MEMBER AND DIAGNOSED THEM WITH CHEMICAL CONJUNCTIVITIS DUE TO EXPOSURE TO FORMALIN FUMES. THE AFFECTED STAFF MEMBER MISSED APPROXIMATELY FIVE (5) HOURS OF WORK WHILST RECEIVING MEDICAL ATTENTION.

  Patient problems: Conjunctivitis

  MAUDE report 20519378 ↗
• MalfunctionJul 17, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 21 JUNE 2024, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING DETAILS: ¿UNDER PROCESS TISSUE NO ERROR CODE/ RAN TO COMPLETION RET A. UNDERPROCESS [SIC] TISSUE, REAGENT CHANGED PRIOR TO RUNNING AND USER CHANGE ONE OF CLEARITE [SIC] BOTTLE 12 WITH CLARIFIER. RAN ON RETORT A TO COMPLETION, NO ERROR PROMPTED. USER DISCOVER WHEN RETRIEVING THE TISSUE WITH STRONG SCENT OF CLARIFIER AND 195 BIOPSY TISSUE AFFECTED.¿ ON 21 JUNE 2024, THE LEICA FIELD APPLICATIONS SPECIALIST ¿ CORE HISTOLOGY, MID-ATLANTIC VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING: ¿¿STAFF MEMBER FILLED CLEARITE [SIC] BOTTLE WITH CLARIFIER¿PER CUSTOMER, 12 HOUR CASSETTES SMELL LIKE VINEGAR (ACID) AFTER PROCESSING, LIKELY DUE TO WAX CONTAMINATION WITH CLARIFER; ALL WAX CHAMBERS HAVE STRONG ACID SCENT. ETHANOL CONCENTRATIONS ON SEVERAL BOTTLES READ HIGHER WITH HYDROMETER THAN IN SOFTWARE....¿ ON 22 JUNE 2024, THE FIELD APPLICATIONS SPECIALIST II PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT: ¿THE OVERNIGHT TECH REPLACED BOTTLE 12 WITH CLARIFIER INSTEAD OF CLEAR-RITE¿RETORT A USED BOTTLE 12 WITH THE INCORRECT REAGENT¿CUSTOMER REPROCESSED BLOCKS FROM RETORT A M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768051 ↗
• MalfunctionJul 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 17 JUNE 2024, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: ¿TISSUE IMPACTED BY CLEANING PROTOCOL. RETORT A HAD 3 BASKETS OF CASSETTES, 214 SPECIMENS CLEANING PROTOCOL PERFORMED BEFORE SPECIMENS REMOVED¿. ON (B)(6) 2024, THE FAS VISITED THE COMPLAINANT¿S SITE TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT AND DOCUMENTED THE FOLLOWING: ¿CUSTOMER REPORTED DRY BIOPSIES WHILE EMBEDDING. CUSTOMER NOTICED THAT CLEANING CYCLE WAS RUN BEFORE BIOPSIES WERE REMOVED FROM RETORT. BIOPSIES WENT THROUGH CLEANING CYCLE ON RETORT A¿CUSTOMER REPROCESSING SPECIMENS OFFLINE, THEN RAN SPECIMENS ON SAME PELORIS UNIT THROUGH NORMAL 1 HOUR PROCESSING PROTOCOL...PROCESSING PROTOCOL ON RETORT A COMPLETED AT 9:59AM. SPECIMENS WERE NOT UNLOADED UNTIL AROUND 11:30AM. SPECIMENS WERE SITTING IN DRAINED RETORT FOR ABOUT 1.5 HOURS. IN THAT TIME, ONE LAB PERSONNEL STARTED A CLEANING CYCLE ON RETORT A WITHOUT CHECKING TO SEE IF RETORT WAS EMPTIED FIRST. MAINTENANCE ON INSTRUMENT IS GOOD.¿ THE FAS ¿HIGHLY RECOMMENDED NOT HAVING SPECIMENS SIT IN A HOT RETORT FOR MORE THAN 15 MINUTES. THIS COULD CAUSE HEAT DAMAGE TO THE TISSUE AND NEGATIVELY IMPACT NUCLEAR DETAIL. THIS ALSO LEAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737895 ↗
• MalfunctionJun 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 17 MAY 2024, THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION: ¿UNDER PROCESSED TISSUE. 12 HR OVERNIGHT RUN TISSUE REMOVED AND APPEARED ¿RUBBERY¿ UNDER PROCESSED¿. ON 20 MAY 2024, THE LOCAL ASSIGNED LEICA FIELD APPLICATIONS SPECIALIST (FAS) ¿ (B)(4) VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING: ¿AT 5:00PM ON 5/16/2024, PA LOADED ROUTINE SPECIMENS IN RETORT B AND SELECTED FACTORY STANDARD 2HR XYLENE PROTOCOL INSTEAD OF FACTORY STANDARD 12HR XYLENE PROTOCOL BY ACCIDENT. NEXT DAY (5/17/2024) AT EMBEDDING, SPECIMENS WERE RUBBERY AND UNDER-PROCESSED. LAB-AID CHANGED ALL REAGENTS ON TISSUE PROCESSOR. PA RELOADED ALL AFFECTED SPECIMENS AND REPROCESSED ON 5/17/2024. ALL TISSUE DIAGNOSABLE - 5/20/2024.¿ THE FAS ¿...CHECKED ALL REAGENT BOTTLES AND FOUND FORMALIN SALTS IN BOTTLES 3, 7, 10. PERFORMED WARM WATER FLUSHES ON THESE STATIONS. RE-DID INITIAL ETHANOL STATION SET UP ON INSTRUMENT. CLEANED BOTH RETORTS AND LLS WITH 70% ETHANOL...¿ THE FAS DOCUMENTED THE AFFECTED PATIENT TISSUE SAMPLES WERE DERIVED FROM AN ¿INCORRECT PROTOCOL SELECTED. PA CLICK FACTORY STANDARD 2HR XYLENE PROTOCOL INSTEAD OF FACTORY STANDARD 12HR XYLENE PROTOCOL.¿ COMPRISING 220 CASSETTES, EXECUTED IN RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534423 ↗
• MalfunctionJun 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 14 MAY 2024, THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION: ¿UNDER PROCESSED TISSUE. POOR PROCESSING STARTED LAST THURSDAY, MORE OCCURRING SINCE THEN, 34 CASES SO FAR. OVER MULTIPLE RUNS HAS INDIVIDUAL CASES UNDER PROCESSED IN SAME PROCESSING RUN WITH WELL PROCESSED TISSUE. HAS TWO PELORIS 3 UNITS. NOT ABLE TO DETERMINE WHICH INSTRUMENT IS AFFECTED. HAVING ISSUES, INCOMPLETE DRAIN YESTERDAY ALCOHOL BOTTLE 3 DID HOT WATER FLUSH. HAS 1 OR TWO A WEEK BLOCKED BOTTLE VENT (LESS OFTEN) MAY NOT BE REPORTED TO LAB DIRECTOR CHANGING BOTTLE ONLY AS PROMPTED. REPROCESSING TISSUE TODAY CONTINUING TO USE INSTRUMENT.¿ ON 15 MAY 2024, THE LEICA LEAD TECHNICAL PROJECT SPECIALIST DOCUMENTED THE AFFECTED PATIENT TISSUE SAMPLES WERE DERIVED FROM MULTIPLE ¿UNKNOWN¿ PROTOCOLS COMPRISING 35 CASSETTES, EXECUTED IN BOTH RETORTS WHICH BEGAN THURSDAY (B)(6). THE AFFECTED TISSUE ARTEFACT WAS DESCRIBED AS ¿UNDERPROCESSED [SIC]¿. ON 17 MAY 2024, THE LOCAL ASSIGNED LEICA FIELD APPLICATIONS SPECIALIST II (FAS) ¿ CORE HISTOLOGY, VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING: ¿HYDROMETERED THE ETHANOL STATIONS, MOST ETHANOL STATION HAD SOME DEGREE OF VARIANCE ABOVE WHAT WAS REPORTED IN THE SOFTWAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516915 ↗
• MalfunctionApr 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 24 JANUARY 2024, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING INFORMATION: ¿HELLO, WE ARE HAVING A PROBLEM PROCESSING THE BIOPSIES, THE MATERIAL LOOKS DRY/BURNT. DIAGNOSES ARE HIGHLY HAMPERED BY THE QUALITY OF PROCESSING. I CONTACTED [NAME] AND SHE TOLD ME THAT WE NEED TO INVESTIGATE AND UNDERSTAND THE REASON FOR THE PROBLEM IN ORDER TO CORRECT IT CORRECTLY. GRATEFUL!¿. ON 02 FEBRUARY 2024, THE LOCAL LEICA FIELD APPLICATIONS SPECIALIST (FAS) DOCUMENTED THE FOLLOWING INFORMATION REGARDING THE CIRCUMSTANCES INVOLVED IN THIS EVENT: ¿THE CUSTOMER COMPLAINT IS THAT THE PROTOCOL FOR BIOPSY SAMPLES NEEDS TO BE ADJUSTED.¿ ON 02 FEBRUARY 2024, LEICA BIOSYSTEMS MELBOURNE RECEIVED INFORMATION FROM THE LOCAL LEICA FIELD APPLICATIONS SPECIALIST THAT ¿NO PATIENT WAS AFFECTED AND ALL SAMPLES WERE DIAGNOSED.¿ NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER. ON 16 FEBRUARY 2024, THE FAS DOCUMENTED ¿I LOOKED AT THE LOGS AND DIDN¿T FIND ANYTHING THAT COULD EXPLAIN THE OVERPROCESSING. THEY USED THE FACTORY 1-HOUR PROTOCOL WITH MINOR CHANGES ON THE ETHANOL 70% STEP SUGGESTED BY [LEICA MANAGER, GLOBAL TECHNICAL SUPPORT - APPLICATIONS] TO AVOID FORMALIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048151 ↗
• MalfunctionMar 19, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 19 FEBRUARY 2024, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING DETAILS: ¿OVER PROCESSED BIOPSY TISSUE THAT WERE PROCESSED TOGETHER WITH BIG SPECIMENS IN A 12 HOUR CYCLE. NOT ALL BIOPSY TISSUES WERE OVER PROCESSED. NO ERROR CODES RAISED. THE PROGRAM RAN TO COMPLETION. THE ALCOHOL CONCENTRATION REPORTED 67,66,72,83,90,98,94,98. FOLLOWED BY CITRACLEAR 99,99,79,94 CONCENTRATION.¿ ON 22 FEBRUARY 2024, THE ASSIGNED FIELD APPLICATIONS SPECIALIST ¿ (B)(4) VISITED THE COMPLAINANT¿S SITE TO ASSESS THE OPERATION AND FUNCTION OF THE INSTRUMENT AND DOCUMENTED THE FOLLOWING: ¿THREE TECHS AND SUPERVISOR CONFIRMED THAT SMALL GASTRIC BIOPSIES ARE BEING PLACED ON 12 HOUR RUN WITH FATTY TISSUE AND BREAST SPECIMENS. INSTRUMENT CLEAN, RETORT AND LIQUID LEVEL SENSORS CLEAN, NO EVIDENCE OF SALT. NO EVIDENCE OF ADIPOSE RESIDUE IN BOTTLES. EOSIN ON BOARD ON BOTTLES 5-10, BOTTLES 3-4 ARE DESIGNATED 70% ETHANOLS AND DO NOT CONTAIN EOSIN. MILD INK RESIDUE IN BOTTLE 4. CUSTOM PROTOCOLS, STANDARD THRESHOLDS. CUSTOMER ONLY USES ONE RETORT. ALL ETHANOLS TESTED WITHIN +/- 5 POINTS OF SOFTWARE. BOTTLES AND RETORTS DON¿T SHOW EVIDENCE OF ADIPOSE RESIDUE OR SALT. NO EVIDENCE OF ADVERSE EVENT CODES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937496 ↗