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	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the customer contacted leica biosystems and reported "slides are not charged.They are saying risk of tissue loss.Some charged some uncharged.".
Additional Manufacturer Narrative
The customer reported white x-tra slides non-clipped (1440), p/n 3800200ae, lot 4900078019 had no charge that could cause tissue loss.No adverse events were reported.Trending analysis from 19 mar 2025 to 19 mar 2026 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.Additional information has been requested from the customer to assist with the completion of the investigation.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.
Additional Manufacturer Narrative
Testing of slides from the same product lot retained by the manufacturer could not replicate the "slides are not charged.They are saying risk of tissue loss.Some charged some uncharged" reported by the customer.The root cause for the "slides are not charged.They are saying risk of tissue loss.Some charged some uncharged" reported by the customer could not be determined by the manufacturer.If additional information is received a follow up mdr 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: 24770926
• Report Number: 1419341-2026-00006
• Device Sequence Number: 18430049
• Product Code: KEW
• UDI-Device Identifier: 20849832025492
• UDI-Public: 20849832025492
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 04/17/2026

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: 4900078019
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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