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

Model Number	HISTOCORE PEARL
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, leica biosystems was contacted by a customer regarding inconsistent processing of tissue samples on their histocore pearl tissue processor.Some samples were described as raw while others had a burned appearance.On august 19 2025, leica biosystems was informed that a total of 41 samples had been impacted by this incident.40 samples were diagnosable.In the one case where a diagnosis was not possible, a re-biopsy was performed.After collection of the new sample material a diagnosis of the patient could be succesfully performed.
Additional Manufacturer Narrative
The investigating engineer, quality assurance & regulatory affairs has determined the following: application issue ¿ wrong reagent changed: it is found that the reagent concentration in the s8 bottle is 85%, leading the instrument used the 85% ethanol as the final ethanol step in the affected run.The concentration is far lower than the required level, resulting in poor quality of tissue processing.As the reagent concentration in the s4 bottle is close to 100% while that in the s8 bottle is close to 80%, the most likely reason is that the customer mistakenly installed s4 and s8 in the opposite positions.The customer was advised to replace all reagents, including the paraffins with fresh reagents.A subsequent test run was performed and all samples were examined and approved by the customer's pathologist.The device was evaluated on-site by a leica biosystems field service engineer.All test performed were passed, showing that the device in in full working order.The device has been released to the customer for validation prior to the usage of clinical samples.

• Brand Name: HISTOCORE PEARL
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong 20120 6; CH 201206
• Manufacturer Contact: sebastian schroeder ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143611
• MDR Report Key: 22882753
• Report Number: 8010478-2025-00026
• Device Sequence Number: 8861161
• Product Code: IEO
• UDI-Device Identifier: 04049188198907
• UDI-Public: (01)04049188198907(11)170116
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 08/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2017
• 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: Female