MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS

Catalog Number	14048858005
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2023, the complainant contacted leica biosystems and reported increasing formalin fumes in the tissue processor, histocore pegasus and the cut-up room in their histopathology room.The complainant reported that their staff were feeling light headed, nauseous, and had headaches.
Additional Manufacturer Narrative
The investigation revealed the following: the incident was user related because the user disregarded the safety instructions.The device was tested and found to be functioning as per manufacturer's expectation.The root cause for the incident cannot be confirmed.It was suspected that improper concentration of chemicals utilized with the device may have caused the fumes.Insufficient ventilation in the work area may have additionally contributed to the incidents.The instructions for use noted sufficient precautions with regards to safety, installation requirements and warnings in relation to the proper use and care for personnel using the device.Recommendation from leica biosystems to the customer was via a "customer facing letter" to follow the clear statements and warnings in the instrument's instructions for use.

• Brand Name: HISTOCORE PEGASUS
• Common Device Name: HISTOCORE PEGASUS
• 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: 16722353
• Report Number: 8010478-2023-00004
• Device Sequence Number: 7989377
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 05/08/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/01/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• 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