UNIDENTIFIED

Description of Event or Problem

ON OR AROUND 06/25/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN INCIDENT INVOLVING A FUJIFILM DEVICE DURING A DEMO. ON OR ABOUT 03/23/2026, THE HCUS CLINICAL SPECIALIST WAS AT (B)(6) HOSPITAL - PLANO (THE "HOSPITAL") TO DEMONSTRATE HOW TO USE NEW FUJIFILM EQUIPMENT TO THE HOSPITAL STAFF. THE DEMONSTRATION USED A FUJIFILM ENDOSCOPE IN CONNECTION WITH AN ENDOSCOPIC ULTRASOUND AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPLIY PROCEDURE ("EUS/ERCP"). AN EUS/ERCP INVOLVES A STERILE WATER BOTTLE CONNECTED TO A CARBON-DIOXIDE INSUFFLATOR. THE INSUFFLATOR DELIVERS A CONTINUOUS FLOW OF CARBON-DIOXIDE GAS INTO THE WATER BOTTLE TO FACILITATE LENS CLEANING AND AUXILIARY IRRIGATION. DURING THE DEMONSTRATION, THE HCUS CLINICAL SPECIALIST CLAMPED THE STERILE WATER BOTTLE TUBING, PREVENTING THE BOTTLE FROM VENTING EXCESS PRESSURE. THE TRAPPED PRESSURIZED GAS CAUSED THE BOTTLE TO BURST (THE "EXPLOSION"). A HOSPITAL STAFF IN ATTENDANCE FOR THE DEMONSTRATION WAS WEARING HEARING AIDS AT THE TIME OF THE EXPLOSION. THE SOUND OF THE EXPLOSION, WHICH WAS MAGNIFIED BY TBE HEARING AIDS, SEVERELY DAMAGED THE HOSPITAL STAFF'S HEARING. FUJIFILM HEALTHCARE AMERICAS CORPORATION IS SUBMITTING THE REPORT DUE TO THE ALLEGED SEVERE DAMAGE TO THE HOSPITAL STAFF'S HEARING. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).