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

Model Number	HISTOCORE PEGASUS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their histocore pegaus, tissue processor.As a result, 5 tissue samples were undiagnosable, and five patients need re-biopsy.
Additional Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available.Following the investigation.
Additional Manufacturer Narrative
An interims report issued by the investigating leica biosystems applications consultant on january 24, 2025, identified the following preliminary conclusions: - analysis of h&e (staining) images obtained from damaged tissue demonstrates artifacts consistent with water contamination.- all alcohol reagents were within the specified purity range for processing.- the affected device was shown to have significant aldehyde contamination in all the xylene bottles and wax baths.This strongly suggests that the water contamination originated from aldehyde in the xylene and wax baths.Inadequate removal of water from the tissue resulted in subpar infiltration of molten wax.This results in the ¿cooked¿ phenomenon observed with the affected biopsy tissues.The affected device will be returned to the manufacturer's workshop for further intensive testing and evaluation.
Additional Manufacturer Narrative
The incident was related to a foreign object, a small metal wire fragment, getting stuck in liquid valve 4.This piece of small metal wire was removed, and tests were repeated at customer site, including further tests on different valves.A logfile analysis did not reveal any abnormal events recorded for the time of the incident.No leakage was found in the rotary valve and the device passed all air manifold and liquid valve performance tests.Based on the original investigation at customer site, as well as further intensive testing and evaluation in the manufacturer's workshop, during which no device-related deficiencies were identified, the final root cause for this incident has been determined to be the following: the introduction of a small foreign object into the liquid system of the device interfered with the proper functionality of liquid valve 4.This is the only case leia biosystems nussloch gmbh has been made aware of for this root cause.This case will therefore be treated as a single case at this time.

• Brand Name: HISTOCORE PEGASUS
• 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: andreas helmstetter ; GM 69226 ; +011 0496224143413
• MDR Report Key: 21206736
• Report Number: 8010478-2025-00020
• Device Sequence Number: 19812436
• Product Code: IEO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/23/2026
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/21/2025; 06/04/2025; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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