MAUDE Adverse Event Report: KNITTEL GLASER SLIDE BOND APEX ADHESIVE; SLIDES, MICROSCOPE

Model Number	SLIDE BOND APEX ADHESIVE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported tissue would not stay on the slide bond apex adhesive, p/n 3800040, lot 4900076974.Trending analysis from 11 dec 2024 to 11 dec 2025 reported no (0) other related occurrences of this issue for this product lot.Retain samples were unavailable to the manufacturer for testing.Information provided by the customer detailed all available samples at the customer site were either used in full or disposed of.As a result, leica biosystems was unable to test samples.The root cause for the "tissue floats away" reported by the customer could not be unequivocally determined from the information available.In the context of tissue analysis, the loss of tissue is deemed recoverable without the need for re-biopsy.This is because the amount of tissue required for analysis is often very small and a portion of the initial sample would have been preserved for further testing.Therefore, in situations where a small amount of tissue is lost during analysis, it is generally considered recoverable without the need for further biopsy.Although the information available indicates that no adverse consequence(s) to a patient(s) has been reported to the manufacturer, the circumstances involved in this complaint have previously resulted in serious injury.If additional information is received a follow up report will be submitted.
Event or Problem Description
On 21 november 2025, a complaint was raised with the following information "customer used apex bond for ihc staining on bond iii and bond prime and noticed that often tissue floats away, the switched to xtra with much better performance." on 15 december 2025, the leica account manager advised the leica associate, quality assurance that the awareness date for this event was 30 october 2025.

• Brand Name: SLIDE BOND APEX ADHESIVE
• 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: 24139693
• Report Number: 1419341-2026-00003
• Device Sequence Number: 14810050
• Product Code: KEW
• UDI-Device Identifier: 20849832016438
• UDI-Public: 20849832016438
• 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
• 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 Expiration Date: 07/26/2026
• Device Model Number: SLIDE BOND APEX ADHESIVE
• Device Catalogue Number: 3800040
• Device Lot Number: 4900076974
• 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: 10/30/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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