IP BIOPSY CASSETTE II, TAPED, GREEN

Additional Manufacturer Narrative

RETAIN SAMPLES WERE NOT AVAILABLE FOR FURTHER TESTING. THE ROOT CAUSE FOR "BIOPSY CASSETTE II TABS BROKEN" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. TRENDING ANALYSIS FROM 10 DEC 2024 TO 10 DEC 2025 REPORTED ONE (1) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. 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 03 DECEMBER 2025, LEICA BIOSYSTEMS WAS MADE AWARE OF AN INCIDENT REPORTED TO HEALTH CANADA BY THE CUSTOMER. THE CUSTOMER PROVIDED THE FOLLOWING DETAILS: "AT EMBEDDING OF OUTPATIENT¿S TISSUE SPECIMEN IN HISTOLOGY DEPARTMENT, THERE SHOULD HAVE BEEN TWO PIECES OF TISSUE IN THE CASSETTE, BUT CASSETTE WAS FOUND EMPTY. INTERNAL TAB ON CASSETTE WAS OBSERVED TO BE BROKEN. GROSSING BASKET WAS EMPTY. ONE PIECE WAS FOUND IN THE PROCESSOR RETORT; THE SECOND PIECE WAS LOST. THE FOUND PIECE OF TISSUE WAS EMBEDDED IN BLOCK X AND THREE LEVELS WERE CUT AND STAINED WITH HEMATOXYLIN AND EOSIN; PATHOLOGIST REVIEWED AND CONFIRMED IT WAS THE CORRECT TISSUE TYPE. SLIDE WAS LABELED AS PART C. BLOCK X WAS MELTED AND TISSUE RE-EMBEDDED IN PART C CASSETTE. (TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN.)" ON 03 DECEMBER 2025, THE FOLLOWING INFORMATION WAS DOCUMENTED: "TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN."