MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS PLUS

Catalog Number	14048858007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected.Also, leica biosystems field service engineer did not detect any technical anomalies with the instrument during the visit and investigation at customer site.Based on the investigation results, the histocore pegasus plus has been functioned according to the factory specifications.Recommendation from leica application specialist was to check, whether the processing protocol is correctly selected based on the tissue size and type, that the reagent will be changed frequently and the threshold and carryover settings are correctly set as described in the instruction for use.
Event or Problem Description
On 05 april 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus, tissue processor.As a result, 250 cassettes with tissue samples were affected.

• Brand Name: HISTOCORE PEGASUS PLUS
• Common Device Name: HISTOCORE PEGASUS PLUS
• 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: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17236342
• Report Number: 8010478-2023-00006
• Device Sequence Number: 14891568
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/30/2023

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 Catalogue Number: 14048858007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown