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 18 september 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 23 september 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 3022446399-2025-00010: female/59 su25: men:3209.Refer to importer mdr 3022446399-2025-00009 for information on the first 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: 23324738
• Report Number: 3022446399-2025-00010
• Device Sequence Number: 9938270
• 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: 59 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/17/2025