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 Code	Insufficient Information (4580)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 25 june 2025, a device malfunction incident was reported to leica biosystems (lbs) technical support.On 26 june 2025, leica biosystems (lbs) received information that patient specimens were unreadable.The lbs field applications specialist (fas) investigating this event with the complainant documented the following, "the specimens processing during this device malfunction occurred sometime during the latter steps of the protocol.The blocks and slides of the specimens from this run were sent to their of site lab for reading.It was discovered that some specimens were unreadable." on 30 june 2025, the lbs fas confirmed with the complainant that, ".It was actually 3 patients re-biopsied relating to the incident that affected the specimens from the date of (b)(6) 2025." on 10 july 2025, the lbs fas provided further confirmation that, "when asked if the affected samples were related to the device malfunction, the customer could not confirm.The customer reported the device malfunction occurred april 27th 2025 and were made aware of unreadable cases on may 16th.The customer estimated that the processing run containing the affected the cases may have been processed just days prior to receive report of the unreadable cases.Per customer, they recommended and performed re-biopsy for 3 impacted patients." the lbs fas further documented, "at the time of discussion, the customer did not want to disclose/provide patient identifiers for the 3 patients.Customer mentioned hippa and seemed concerned surrounding that.".

• 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: 22602130
• Report Number: 3022446399-2025-00007
• Device Sequence Number: 12108471
• 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