MAUDE Adverse Event Report: WHITE X-TRA SLIDES NON-CLIPPED (1440); SLIDES, MICROSCOPE

Model Number	WHITE X-TRA SLIDES NON-CLIPPED (1440)
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported tissue not sticking to white x-tra slides non-clipped (1440), p/n 3800200ae, lot 4900074660.Trending analysis from 04 dec 2024 to 04 dec 2025 reported no (0) other related occurrences of this issue for this product lot.The product history was reviewed and did not identify information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.Retain samples were unavailable for testing.The root cause could not be unequivocally determined from the information available.If additional information is received a follow up report will be submitted.
Event or Problem Description
On 05 december 2025, a complaint was raised with the following information: "the tissue do not stick to the slides".On (b)(6) 2025, the leica senior applications consultant advised that there was additional tissue available for re-staining and no patient required a re-biopsy as a result of this event.On 26 december 2025, the leica senior applications consultant advised the leica associate, quality assurance that the awareness date for this event was 24 october 2025.

• Brand Name: WHITE X-TRA SLIDES NON-CLIPPED (1440)
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 24139751
• Report Number: 1419341-2026-00004
• Device Sequence Number: 5430042
• Product Code: KEW
• UDI-Device Identifier: 20849832025492
• UDI-Public: 20849832025492
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WHITE X-TRA SLIDES NON-CLIPPED (1440)
• Device Catalogue Number: 3800200AE
• Device Lot Number: 4900074660
• 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: 10/24/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown