PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
Received Aug 13, 2025 · Event occurred Jul 16, 2025
Report 1419341-2025-00033 · MDR key 22800226
Device
Generic name
Slides, Microscope
Manufacturer
Leica Biosystems Richmond Inc.Model number
PERMAFLEX PLUS ADHESIVE SLIDES, WHITECatalog number
3800014
Lot number
091624-2
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
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.
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.
Description of Event or Problem
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.