TISSUE-TEK® PARAFORM® BIOPSY CASSETTES, 13 X 13 MM; 500 CASSETTES/BOX

Additional Manufacturer Narrative

SAKURA FINETEK EUROPE ADDITIONALLY REPORTED THAT UPON ASKING THE CUSTOMER OF ANY PRIOR OBSERVATION OR REPORT FOR SIMILAR MISSING BLUE SPONGE ON TISSUE-TEK PARAFORM BIOPSY 13X13 CASSETTE. THE CUSTOMER REPORTED THAT THE BATCH OF CASSETTES INVOLVED IN THE INCIDENT (FMPM240331) AND A RANDOM BATCH (FMPM240226) WERE CHECKED FOR DEFECTS. BATCH FMPM240331 CONTAINED 5 CASSETTES WITH DEFECTS AND BATCH FMPM240226 CONTAINED 7 CASSETTES WITH DEFECTS PERTAINING TO MISSING BLUE SPONGE. AS IT IS A POSSIBILITY THAT THE FOAM IS MISSING OR LOOSE FROM THE INSERT, A VISUAL WARNING IS IMPLEMENTED ON THE LABEL OF TISSUE-TEK PARAFORM BIOPSY 13X13 CASSETTE INDICATING TO NOT USE THE INSERT WHEN THE FOAM IS MISSING. A WRITTEN WARNING IS STATED IN THE INSTRUCTIONS FOR USE. PER SAKURA FINETEK EUROPE, THESE WERE UNFORTUNATELY NOT FOLLOWED BY THE USER. AS TISSUE WAS LOST AND NO REBIOPSY COULD BE PERFORMED, THE INCIDENT LED NO DIAGNOSIS FOR THE PATIENT UNDER SURVEILLANCE.

Description of Event or Problem

SAKURA FINETEK EUROPE NOTIFIED SAKURA FINETEK USA ON 14- AUG-2024 ABOUT THE INCIDENT THAT OCCURRED ON (B)(6) 2024 INVOLVING TISSUE-TEK PARAFORM BIOPSY 13X13 CASSETTE AT A CUSTOMER IN IRELAND. THE BLUE SPONGE IN THE PARAFORM BIOPSY 13X13 CASSETTE WAS MISSING AND TISSUE WAS LOST THROUGH THE GAP IN THE CAGE OF THE LID DURING THE HANDLING AND PROCESSING OF THE TISSUE. THE CUSTOMER DID CLARIFY THAT THE USER IS NOT SURE IF THE BLUE SPONGE WAS PRESENT BEFORE TISSUE WAS INTRODUCED IN THE CASSETTE. IT WAS REPORTED PER SAKURA FINETEK EUROPE'S COMMUNICATION WITH THE CUSTOMER THAT THE ISSUE OF MISSING SPONGE WAS CHECKED WITH THE CUSTOMER'S STAFF, AND IT HAS BEEN NOTED THAT THE TISSUES HAVE BEEN MISSING/LOOSE FROM THE CASSETTE FROM TIME TO TIME AT THE CUSTOMER'S FACILITY. THE CUSTOMER ALSO MENTIONED THAT LABORATORY HAS PUT IN EXTRA CHECKS IN PLACE TO PREVENT THIS RECURRING BUT FELT THE NEED TO FEEDBACK THAT THERE IS A RISK OF TISSUE LOSS IF THE SPONGE FALLS OUT AND IS NOT NOTICED AS THE GAPS IN THE LID ARE TOO LARGE FOR SMALL BIOPSY SAMPLES. ONE TISSUE WAS IMPACTED. THE BIOPSY (TISSUE) THAT LOST WAS POLYP TISSUE OF A PATIENT UNDER SURVEILLANCE FOR PREVIOUS TUBULOVILLOUS ADENOMA. THE CUSTOMER MENTIONED THAT IT WAS AN UNREPLACEABLE TISSUE SAMPLE AND IT WOULD BE IMPOSSIBLE TO QUANTIFY RISK IN THE LOST SAMPLE LOST OR TO EXCLUDE MALIGNANCY. ACCORDING TO THE CUSTOMER E-SAMPLING WITH A SECOND PROCEDURE WILL NOT RECTIFY THE LOSS. IT IS UNCLEAR AT THE TIME OF THE REPORT IF THE PATIENT UNDERWENT REBIOPSY.