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

Model Number	HISTOCORE PEGASUS
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigating engineer, quality assurance & regulatory affairs has determined the following: it can be confirmed that the poor tissue processing quality occurred right after two bottles of ethanol were replaced.And after the problem occurred, the reagents were replaced again, and the processing quality returned to normal.Upon the above information, it can be determined that there were some human errors during the reagent replacement process, which resulted in the ethanol concentration after replacement failing to meet the usage requirements and thus causing poor tissue processing quality.The customer has conducted an internal investigation and has communicated to leica biosystems that they are aware of the underlying issue at hand.The customer has informed their relevant personnel on how to prevent a recurrence of the issue in the future and has declined additional remedial training by leica biosystems at this time.
Event or Problem Description
On 05 november 2025, leica biosystems received information from the customer that some patient cases are not diagnosable.No further information regarding the number of undiagnosable cases or patient impact has been provided to the manufacturer to date.On 23 october 2025, leica biosystems received a complaint detailing "under processed biopsy tissue on both retorts.The runs completed with no errors." on 31.October, leica biosystems was informed that the affected samples had been reprocessed.At this time additional information was provided stating that some impacted tissues still had to be diagnosed.On 05 november 2025, leica biosystems received the information from the customer that they unfortunately will have some cases that are not diagnosable.The customer is in the process of determining what cases are not diagnosable, and they will they will inform the leica biosystems technical specialist once they get confirmation from the pathologists.

• Brand Name: HISTOCORE PEGASUS
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch ; GM
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai, pudong 20120 6; CH 201206
• Manufacturer Contact: sebastian schröder ; heidelbergerstr. 17-19; nussloch 69226 ; GM 69226 ; 6224143611
• MDR Report Key: 23591892
• Report Number: 8010478-2025-00033
• Device Sequence Number: 15997140
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397(11)241105
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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 PEGASUS
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 11/05/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown