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

Model Number	HISTOCORE PEGASUS
Medical Device Problem Codes	Use of Device Problem (1670); 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
Event or Problem Description
Leica biosystems (lbs) received a complaint of underprocessed tissue.On (b)(6) 2025, the complainant provided the following information to lbs, "there was 1 case that we were not able to get a definitive diagnosis.I have not heard if they are going to re-biopsy or not though.I can make sure to let you know once i know more." on (b)(6) 2025, the lbs field applications specialist (fas) investigating this event with the complainant received the following update, "the supervisor just sent me an update.There were actually 2 cases that were unable to be diagnosed, and they are going to re-biopsy." the following is the full patient identifier information for importer mdr (b)(4): female/67 su25:cm:3233.Refer to importer mdr (b)(4) for information on the second patient case impacted.

• Brand Name: HISTOCORE PEGASUS
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 23324720
• Report Number: 3022446399-2025-00009
• Device Sequence Number: 15937127
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025
• Report Date (Section F): 10/17/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/17/2025