IP BIOPSY CASSETTE II, TAPED, PINK

Description of Event or Problem

ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "ON-SITE WITH CUSTOMER ON (B)(6) 2025. MANAGER [NAME] INFORMED ME OF ISSUE WITH 38440501: IP BIOPSY CASSETTE II, TAPED, PINK. FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. ISSUE HAS OCCURRED ALL WEEK WHERE TISSUE IS BEING LOST. PER [NAME], THIS HAS OCCURRED WITH 3 DIFFERENT PAS EVEN AFTER PARTICULAR CARE IS BEING TAKEN. PAS FEEL THAT CASSETTES SEEM "SOFTER" AND MORE FRAGILE THAN PREVIOUSLY. SWITCHED TO NEW LOT # AND TAKING EXTRA PRECAUTIONS. THIS SITE IS ALSO USING THE SAME CASSETTE IN GREEN AND YELLOW, NO REPORTED ISSUES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED IP BIOPSY CASSETTE II, TAPED, PINK, P/N 38440501, UNKNOWN LOT WHERE THE FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST. TRENDING ANALYSIS FROM (B)(6) 2024 TO (B)(6) 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE ROOT CAUSE FOR THE "FLANGE HAS BEEN BREAKING OFF, CASSETTES OPENING DURING PROCESSING, AND TISSUE HAS BEEN LOST" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.