MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA TP1020; PROCESSOR, TISSUE, AUTOMATED

Model Number	LEICA TP1020 VF/ACCESSOR. (100/120/230/240V/50-60HZ)
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194)
Date of Event	05/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, leica biosystems (lbs) received a device malfunction complaint where laboratory staff members were exposed to reagent fumes.The complainant informed lbs that several staff members reported dizziness, vomiting, nausea, headaches and more and several went to urgent care for further evaluation and testing.The lbs field applications specialist (fas) investigating this event with the complainant documented the following, "customer mentioned the incident which everyone felt sick was during the first week of may and when asked to confirm the date, she mentioned she thinks it was may 4th and based the date off timestamps of emails and text messages surrounding the incident." on (b)(6) 2025, the lbs fas documented the following information from the complainant, ".3 staff members decided among themselves to seek medical treatment.2 of the 3 staff members were found to have a presence of over-exposure based on testing." the type of testing is unknown.The complainant also mentioned, ".One of the staff members was recommend glutathione injection, ivs, hyperbaric oxygen." when the customer was asked about the type of treatment, the customer did not disclose any details aside from what was recommended for the single individual mentioned previously and that the staff members that sought treatment were found to have elevated levels of chemical exposure.Specific type of treatment was not provided.The lbs fas documented, "when asked, the customer did not want to provide identifier information about the 2-3 staff members that sought medical treatment.Customer did mention she did not want to request that information from the staff due to hippa concerns.".

• Brand Name: LEICA TP1020
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 22602469
• Report Number: 3022446399-2025-00006
• Device Sequence Number: 21266667
• Product Code: IEO
• UDI-Device Identifier: 04049188003102
• UDI-Public: (01)04049188003102(11)180525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025
• Report Date (Section F): 07/24/2025

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: LEICA TP1020 VF/ACCESSOR. (100/120/230/240V/50-60HZ)
• Device Catalogue Number: 1491020US02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Event Location: Other
• Date Report to Manufacturer: 07/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/24/2025