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

Model Number	HISTOCORE PEGASUS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
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 the usage of an insufficient concentration of ethanol/alcohol as the final step in dehydration.The insufficient ethanol concentration was not adequate to completely replace the water in the tissue, ultimately leading to dehydration failure.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 follow the detailed description in the instruction for use.
Event or Problem Description
On (b)(6) 2024 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their histocore pegasus, tissue processor.As a result, 6 six) tissue samples were undiagnosable.

• 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: heather jensen ; 5205 us highway 12; nussloch, IL 60071 ; 6308152988
• MDR Report Key: 20244640
• Report Number: 8010478-2024-00016
• Device Sequence Number: 17983319
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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
• Report Date (Section B): 09/18/2024

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: 14048858009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown