MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND INC. WHITE NON CLIP PERMASLIDE PLUS ADHESIVE; SLIDES, MICROSCOPE

Model Number	WHITE NON CLIP PERMASLIDE PLUS ADHESIVE
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported liver tissue falling off of white non clip permaslide plus adhesive, p/n 3800455, lot 4900075392.No adverse events were reported.Trending analysis from 13 jun 2024 to 13 jun 2025 reported no (0) other related occurrences of this issue for this product lot.The product history was reviewed and did not identify any information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.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 29 may, leica biosystems received the following information: "we just recently had some issues with livers, it not a normal thing but.Tissue fall off.We occasionally have a slide or two once a month at worst.In this case it was closer to 20-30 slides that were affected." on 14 june 2025, the customer advised leica biosystems that the tissue was non-clinical tissue and additional tissue was available.No adverse consequence(s) to a patient(s) has been reported to the manufacturer to date.
Additional Manufacturer Narrative
Manufacturer testing of retain samples was unable to replicate the "tissue fall off" reported by the customer.The root cause for the "tissue fall off" reported by the customer could not be unequivocally determined from the information available.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: WHITE NON CLIP PERMASLIDE PLUS ADHESIVE
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• 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: 22333392
• Report Number: 1419341-2025-00029
• Device Sequence Number: 13043700
• Product Code: KEW
• UDI-Device Identifier: 20849832023153
• UDI-Public: 20849832023153
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/11/2025

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: 03/10/2026
• Device Model Number: WHITE NON CLIP PERMASLIDE PLUS ADHESIVE
• Device Catalogue Number: 3800455
• Device Lot Number: 4900075392
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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