PERMAFLEX PLUS ADHESIVE SLIDES, WHITE

Additional Manufacturer Narrative

THE ROOT CAUSE FOR THE "TISSUE FALL OFF" 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 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 090324-1 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: "CUSTOMER WAS HAVING ISSUES WITH TISSUE FALL OFF WITH STANDARD H&E." 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.