WHITE NON CLIP PERMASLIDE PLUS ADHESIVE

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.

Description of Event or Problem

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.