MAUDE Adverse Event Report: Leica Microsystems Ltd. Shanghai HistoCore PEGASUS Plus; Processor, Tissue, Automated

Model Number	HistoCore PEGASUS Plus
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer contacted leica biosystems and reported "a processing quality issue affecting small tissue specimens, including endoscopic and biopsy samples.During histological quality control, alterations were observed primarily in nuclear definition, which could potentially impact diagnostic evaluation." on (b)(6) 2026, the leica representative advised "according to the customer, although the affected samples presented processing quality issues that mainly impacted nuclear visibility, all affected cases were reviewed and reported by experienced pathologists.The report also indicates that no re-biopsies were required and that no patient harm was identified." on (b)(6) 2026, the customer advised the impact to patients had been updated and provided the following information "all affected cases required additional tissue sections and repeat h&e staining.The customer confirmed that eight cases could not be reported for hormone receptor evaluation and that one core biopsy could not be diagnosed.A repeat biopsy was performed, and the customer confirmed that the event resulted in delays in patient diagnosis and patient care." identifiers for the affected patients were requested but have not been provided.
Additional Manufacturer Narrative
The root cause of the customer's reported suboptimal tissue processing was determined to be incorrect user configuration of the change and final thresholds for multiple reagents.Because these thresholds were set outside the recommended parameters, the instrument continued to use reagents beyond their intended replacement points.This resulted in reagents with concentrations below the required specifications being used during the processing protocol, ultimately leading to poor tissue processing quality.

• Brand Name: HistoCore PEGASUS Plus
• Common Device Name: Processor, Tissue, Automated
• Manufacturer (Section D): Leica Microsystems Ltd. Shanghai; 258 jinzang road; shanghai 00002 0120; CH 0000201206
• Manufacturer (Section G): Leica Biosystems Nussloch GmbH; heidelbergerstrasse 17-19; nussloch 00000 6922; GM 0000069226
• Manufacturer Contact: sebastian schröder ; heidelbergerstrasse 17-19; nussloch 00000-6922 ; GM 0000069226 ; +049()6224143611
• MDR Report Key: 50132712
• Report Number: 8010478-2026-00012
• Device Sequence Number: 10528308
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)230223
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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 PEGASUS Plus
• Device Catalogue Number: 14048858007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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