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	09/09/2025
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 s7 bottle containing 79 % ethanol was removed from the instrument for 3 seconds, reinserted, and the station properties were reset to 100 % ethanol.The concentration of s7 was set to 100 % in the system but reagent in s7 was not replaced and its actual concentration was at 79 %.Bottle 7 was used as the final reagent ethanol in multiple runs.The insufficient ethanol concentration was not adequate to completely replace the water in the tissue, ultimately leading to poor tissue processing quality.The customer has replaced all reagents and performed a test run with no issues reported.The customer has resumed usage of the device in preparation of tissue samples for patient diagnosis without issues.It was recommended to the customer to set up separate log in profiles for every user instead of using a generic profile for all users.The device is working as intended.
Event or Problem Description
On (b)(6) 2025, leica biosystems received a complaint that a customer experienced suboptimal tissue processing on their histocore pegasus tissue processor.According to the customer, there were two runs performed on (b)(6) 2025, and one run performed on (b)(6) 2025, which were affected.The tissue was described by the customer as under processed.After the run performed on (b)(6) 2025, the customer suspended the use of the device.On (b)(6) 2025, leica biosystems nussloch gmbh was informed that one patient sample was unable to be diagnosed.On (b)(6) 2025, leica biosystems nussloch gmbh received further information that the number of non-diagnosable cases had increased to two and that for both cases a re-biopsy would be performed.

• 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: sebastian schröder ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143611
• MDR Report Key: 23308217
• Report Number: 8010478-2025-00032
• Device Sequence Number: 20043364
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397(11)240219
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 10/16/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Date Device Manufactured: 02/19/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Female