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

Model Number	WHITE X-TRA SLIDES NON-CLIPPED (1440)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported seeing tissue float away when using white x-tra slides non-clipped (1440), p/n: 3800200ae, lot: 4900072897.Trending analysis from 23 dec 2024 to 23 dec 2025 reported no (0) other related occurrences of this issue for this product lot.As manufacturer investigation of this complaint by leica biosystems is in progress, the root cause of this event has not yet been determined.If additional information is received a follow up mdr will be submitted.
Event or Problem Description
On (b)(6) 2025, the customer contacted leica biosystems and reported "with certain antibodies: on (b)(6), p16, cyclin, inhibin, er, pr, c-erb, beta catenin, ki67, the tissue floats off the leica x-tra slides." no adverse impact to a patient has been reported to the manufacturer to date.
Additional Manufacturer Narrative
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.Return for lot 4900072897 was tested for tissue adhesion.Three different tissue types (tonsil, skin, and liver) were cut and mounted on the slides.All slides were run through an h&e on the stainer.Upon h&e completion, no slides showed any issues with tissue adhesion.The root cause could not be unequivocally determined from the information available.If additional information is received a follow up report will be submitted.

• Brand Name: WHITE X-TRA SLIDES NON-CLIPPED (1440)
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer (Section D): KNITTEL GLASER; varrentrappstrasse 3-5; braunschweig 00000 3811; GM 0000038114
• Manufacturer (Section G): KNITTEL GLASER; varrentrappstrasse 3-5; braunschweig 00000 3811; GM 0000038114
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 24014595
• Report Number: 1419341-2026-00001
• Device Sequence Number: 21470246
• Product Code: KEW
• UDI-Device Identifier: 20849832025492
• UDI-Public: 20849832025492
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/18/2026

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 Expiration Date: 04/30/2026
• Device Model Number: WHITE X-TRA SLIDES NON-CLIPPED (1440)
• Device Catalogue Number: 3800200AE
• Device Lot Number: 4900072897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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