LEICA RM2235

Description of Event or Problem

ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "USER CUT FINGER - THE STAGE HOLDING THE BLADE IS USUALLY LOCKED IN PLACE. HOWEVER, AFTER THE PM, THE STAGE WAS LEFT LOOSE. WHEN THE SCIENTIST WHEN TO INSERT THEIR BLADE, THE STAGE MOVED AND SHE RECEIVED A DEEP CUT ON HER THUMB. THE SCIENTIST NEEDED TO RECEIVED MEDICAL CARE FROM (B)(6) EMERGENCY DEPARTMENT". THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "ON THURSDAY THE (B)(6), ONE OF THE SCIENTISTS BADLY CUT THEIR FINGER ON ONE OF THE MICROTOMES THAT RECENTLY HAD A PM." ON (B)(6) 2025, LEICA BIOSYSTEMS WAS ADVISED WHILST USING THE INSTRUMENT A USER " ... RECEIVED A DEEP CUT ON HER THUMB. THE SCIENTIST NEEDED TO RECEIVED MEDICAL CARE FROM (B)(6) EMERGENCY DEPARTMENT". ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING CLARIFYING INFORMATION REGARDING THE INJURY TO THE USER: "THE STAFF MEMBER ATTENDED (B)(6) DURING WORK HOURS. THEY WERE AWAY FOR MAYBE 2 HOURS THEN WENT HOME. THE WOUND WAS GLUED SHUT (NO STITCHES) THEN BANDAGED."

Additional Manufacturer Narrative

MANUFACTURER INVESTIGATION OF THE INFORMATION PROVIDED FOUND THE CUSTOMER DID NOT WEAR CUT­RESISTANT GLOVES AND DID NOT CONFIRM THAT ALL CLAMPING LEVERS WERE SECURE ON THE LEICA RM2235 MICROTOME. DURING THE BLADE INSTALLATION, THE BLADE HOLDER BASE BECAME LOOSE DUE TO THE CLAMPING LEVER NOT BEING TIGHTENED, CAUSING THE CUSTOMER'S FINGER TO BE CUT BY THE BLADE. PREVENTATIVE MAINTENANCE CONDUCTED ON THE INSTRUMENT PRIOR TO THIS INCIDENT CONFIRMED THAT THE CLAMPING SYSTEM AND LEVER OF THE INSTRUMENT WERE ALL NORMAL, THE PM PROCESS WAS COMPLETED WITHOUT ERRORS, AND THE HOLDER BASE WAS FIRMLY TIGHTENED. MANUFACTURER EVALUATION OF THE INFORMATION PROVIDED FOUND THE ROOT CAUSE OF THE USER " ... RECEIVED A DEEP CUT ON HER THUMB." WAS DUE TO AN UNLOCKED STAGE MOUNT ON THE LEICA RM2235 MICROTOME. THE ROOT CAUSE FOR THE UNLOCKED STAGE MOUNT COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE.