TISSUE-TEK® PARAFORM® CORE BIOPSY CASSETTES

Additional Manufacturer Narrative

THE CASSETTE CANNOT BE OPENED BY THE INSTRUMENT DURING THE PROCESS. THIS WOULD INDICATE THAT THE INSERT GOT STUCK SOMEWHERE WHEN REMOVING THE CASSETTE FROM THE MAGAZINE, POSSIBLY DUE TO INCORRECT/NOT FULL CLOSURE OF THE INSERT BY THE CUSTOMER. CHECKING THE ERROR LOG OF THE 25TH OF MARCH SAKURA TECHNICAL SUPPORT PERSONNEL NOTED SOME "OPEN LID" REPORTS. THIS INDICATES THAT THE CLOSING OF THE CASSETTE IS NOT ALWAYS PROPERLY DONE BY THE CUSTOMER. THIS WAY IT CAN GET STUCK, WHICH CAN CAUSE THE INSERT TO BE PUSHED OUT OF THE CASSETTE, CAUSING IN THE TISSUE LOSS.

Description of Event or Problem

SAKURA FINETEK EUROPE NOTIFIED SAKURA FINETEK USA ON 02-APR-2025 ABOUT THE INCIDENT THAT OCCURRED ON (B)(6) 2025 AT A HEALTHCARE FACILITY IN THE UK. THE CUSTOMER WAS USING AN INSTRUMENT FROM SAKURA FINETEK EUROPE B.V. AS PART OF THE HISTOLOGICAL PROCESS. THIS INSTRUMENT IS USING SAKURA TISSUE-TEK® PARAFORM® CORE BIOPSY CASSETTES TO HOLD BIOPSY DURING THE PROCESSING. ON (B)(6), 2025 CUSTOMER REPORTED THAT THE INSERT WAS RIPPED FROM FRAME OF THE CASSETTE. THE LID WAS OPENED AND THE TISSUE WAS LOST. THE CASSETTE FRAME WAS FOUND IN THE RECOVERY AREA AND THE INSERT WAS FOUND OPEN WITH THE LID DETACHED INSIDE THE INSTRUMENT ON THE SILVER PLATE TO THE LEFT OF THE ACCORDION AT THE BACK OF THE BASE MOUNDS. THE INSTRUMENT WAS SEARCHED FOR THE MISSING TISSUE BUT IT WAS NOT RECOVERED. THE TISSUE WAS SOUGHT EXTERNALLY ALSO (IN TISSUE PROCESSOR, AT GROSSING ETC). ALL TISSUE WAS LOST FOR THIS SAMPLE WITH NO TISSUE REMAINING IN THE POT. A RE-BIOPSY WILL BE NECESSARY.