MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEARL; PROCESSOR, TISSUE, AUTOMATED

Model Number	HISTOCORE PEARL
Medical Device Problem Codes	Device Ingredient or Reagent Problem (2910); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On august 06 2025, leica biosystems received a complaint that one of our customers experienced suboptimal tissue processing in one run on their histocore pearl tissue processor on (b)(6)2025.Through further communication with the customer it was determined that also samples processed in one run on (b)(6)2025, and several samples processed between (b)(6)2025 showed suboptimal tissue processing.It was further determined that the customer only uses the histocore pearl for the processing of human non-clinical tissues samples for research purposes.Therefore, no patients were negatively impacted by this event.
Event or Problem Description
On (b)(6) 2025 leica biosystems received a complaint that one of our customers experienced suboptimal tissue processing in one run on their histocore pearl tissue processor on (b)(6) 2025.Through further communication with the customer it was determined that also samples processed in one run on (b)(6) 2025, and several samples processed between (b)(6) 2025 showed suboptimal tissue processing.It was further determined that the customer only uses the histocore pearl for the processing of human non-clinical tissues samples for research purposes.Therefore no patients were negatively impacted by this event.
Additional Manufacturer Narrative
On september 25, 2025, the investigating leica biosystems engineer, quality assurance & regulatory affairs reported the following: application issue ¿ wrong reagent changed no error that would affect the processing protocol was found in the log.After measuring the ethanol concentration in each reagent bottle, some deviations in the ethanol percentages were observed.Since all reagents have been replaced with fresh ones, all test results are acceptable.It is suspected that the customer may have accidentally filled in the wrong ethanol which led to the poor tissue processing quality.An analysis of the device logs showed that there were no error codes recorded associated with the event that would have affected the processing protocol.An examination of the device at the customer site by the leica biosystems application consultant team lead revealed that there were deviations with the ethanol gradient concentration percentages.An incorrect ethanol gradient can have a negative impact on the processing quality of tissue samples.The customer was advised to replace all reagents with fresh stock.Following the replacement a test run was performed, and the test samples were processed with the expected quality.Following the run filling levels and ethanol concentrations were determined to be within specifications.The customer has purchased a hydrometer and has created a plan to document all future reagent changes.On (b)(6) 2025, leica biosystems was informed by the customer that following the implementation of the above-mentioned process changes the device is performing as expected.

• Brand Name: HISTOCORE PEARL
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai, pudong 20120 6; CH 201206
• Manufacturer Contact: sebastian schröder ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143611
• MDR Report Key: 23036131
• Report Number: 8010478-2025-00027
• Device Sequence Number: 13093675
• Product Code: IEO
• UDI-Device Identifier: 04049188198907
• UDI-Public: (01)04049188198907(11)240422
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HISTOCORE PEARL
• Device Catalogue Number: 14049350667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown