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
Additional Manufacturer Narrative
The leica biosystems field application specialist has has communicated with the customer and confirmed that the customer placed the instrument in off-site storage.The customer does not intend to return the device to their laboratory or provide alternatice access to the device for further inspection or testing.Therefore, no conclusive root cause can be established for this incident.Although the root cause of this case cannot be confirmed due to insufficient information, we have made speculations about possible causes below: suspected cause ¿ wax bath improper placement / carousel deviation; due to the instrument was moved offsite to a storage unit facility and no longer in a lab space, the onsite inspection is unavailable.Based on the only available photos and event description, this case has the following suspected causes: if the wax bath is placed correctly, the most likely cause of the accident is that the instrument has been in use for a long time, and the carousel gradually deviates from its original position during operation, preventing the sample basket from aligning with the center of the wax bath, resulting in a collision.A skewed lid hook or a faulty verpos pcb can also cause such an accident.However, according to the provided photos, the wax bath is not tilted to the left or right, but outward from the center of the circle.This is more like the wax bath was hit by the descending sample basket due to improper placement, rather than a malfunction of the instrument itself.
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 them 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 (b)(6) 2025 and were made aware of unreadable cases on (b)(6).The customer estimated that the processing run containing the affected cases may have been processed just days prior to receiving 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; heidelbergerstrasse 17-19; 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong 20120 6; CH 201206
• Manufacturer Contact: andreas helmstetter ; heidelbergerstrasse 17-19; GM 69226 ; 6224143413
• MDR Report Key: 22586154
• Report Number: 8010478-2025-00024
• Device Sequence Number: 15788017
• 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: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2018
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown