APEX SUPERIOR ADHESIVE SLIDE - WHITE

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.

Description of Event or Problem

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.