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 Code	Insufficient Information (4580)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 28 november 2024 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their histocore pegasus, tissue processor.As a result three (3) tissues were undiagnosable.
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
The investigation revealed the following: the instrument logs were analyzed by the lbs engineer, quality assurance & regulatory affairs and no instrument error was detected during the processing steps that could conceivably be linked to the damaged tissue.The incident was user related due to an application issue.The root cause of this adverse event was an issue with the reagent replacement process involving the s15 bottle.The improper replacement caused the instrument to use insufficient concentration xylene in the s15 bottle during the final xylene step of the affected run.This xylene concentration was far below the required 100%.As a result, the insufficient concentration of xylene was not adequate to completely replace the ethanol, preventing the paraffin from properly infiltrating the cells and leading to poor tissue quality.The insufficient concentration of xylene, which contained some ethanol and formalin contamination due to the normal carryover of reagents from one step to the other, was used as the final xylene step before the paraffin steps.This insufficient xylene was carried into the retort and subsequently into the paraffin bath, introducing the contamination into the paraffin baths and causing the observed bubbles to form.Based on the investigation results, as well as the remedial actions carried out by the application consultant, we as the manufacturer confirm the instrument is now working according to factory specifications.A customer facing letter was sent out to the customer with recommendation, to perform a deep cleaning of the equipment and replacement of all reagents for fresh ones.After an additional visit of the customer's site, they informed the field applications specialist, that they have been operating the equipment normally for some time.As a result, they have decided not to proceed with the deep clean due to the lack of reagent availability.

• 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 ; heidelbergerstr. 17-19; nussloch 69226 ; GM 69226 ; 0496224143413
• MDR Report Key: 21025046
• Report Number: 8010478-2024-00018
• Device Sequence Number: 15704375
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397(11)240709
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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?: No
• Distributor Facility Aware Date: 11/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2024
• 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