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

Model Number	PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported tissue falling of permaflex plus adhesive slides, white, p/n 3800014, lot 091624-2 while running standard h&e.No adverse events were reported.Device history review was completed.There were no deviations or non-conformances associated with this lot.Trending analysis reported no (0) other related occurrences of this issue for this product lot.Quality control testing was complete and passed.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 16 july 2025, leica biosystems received the following information: "tech had issues picking up the tissue in their waterbath.Tissue would not stick to slide.Customer then switched to different slide and then worked fine." as of 13 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.
Additional Manufacturer Narrative
Retain samples were unavailable for additional testing.The root cause for the "tissue not sticking to slides" 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: PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer (Section G): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 22800226
• Report Number: 1419341-2025-00033
• Device Sequence Number: 8771180
• Product Code: KEW
• UDI-Device Identifier: 20849832023146
• UDI-Public: 20849832023146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 09/16/2025
• Device Model Number: PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
• Device Catalogue Number: 3800014
• Device Lot Number: 091624-2
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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