MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND INC. APEX SUPERIOR ADHESIVE SLIDE - WHITE; SLIDES, MICROSCOPE

Model Number	APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440)
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported tissue no longer sticks to apex superior adhesive slide - white (1440), p/n 3800080e, lot 4900073503 in the water bath.Trending analysis from 29 jul 2024 to 29 jul 2025 reported one (1) other related occurrence of this issue for this product lot.A review of the product history did not identify information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.Manufacturer testing of retain samples was conducted by cutting multiple multi-tissue control blocks and performing the tissue adhesion protocol for apex slides.After microscopic evaluation it was found that there was tissue loss and tissue disruption.The root cause for the "tissue no longer sticks" reported by the customer could not be unequivocally determined from the information available.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 mdr will be submitted.
Event or Problem Description
On 22 july 2025, leica biosystems received information that "tissue no longer sticks as on the slide when placing tissue after cutting.User has to "fish" for cut tissue in the waterbath." as of 20 august 2025, leica biosystems has not received information as to either the final status of the patient tissue samples involved in this event or the patient impact/outcome.No adverse consequence(s) to a patient(s) has been reported to the manufacturer to date.

• Brand Name: APEX SUPERIOR ADHESIVE SLIDE - WHITE
• 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: 22856311
• Report Number: 1419341-2025-00034
• Device Sequence Number: 21079313
• Product Code: KEW
• UDI-Device Identifier: 20849832023221
• UDI-Public: 20849832023221
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/21/2025

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: 09/02/2025
• Device Model Number: APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440)
• Device Catalogue Number: 3800080E
• Device Lot Number: 4900073503
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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