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Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, ON (b)(6) 2026, THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY FOR GALLSTONES IN THE OPERATING ROOM. THE IMAGE FLICKERED AND AN IDENTIFICATION ERROR ALARM APPEARED DURING THE OPERATION, CAUSING A BRIEF INTERRUPTION OF THE SURGERY. THE ISSUE WAS ATTRIBUTED TO A SIGNAL ACQUISITION AND TRANSMISSION FAILURE OF THE CONNECTING CABLE, WHICH RESULTED IN SCREEN FLICKERING AND ERROR ALERTS. THE SURGERY WAS COMPLETED AFTER EMERGENCY HANDLING. THE DEVICE HAS BEEN TAKEN OUT OF SERVICE FOR MAINTENANCE AND WILL BE EVALUATED FOR USE AFTER THE CONNECTING CABLE IS REPLACED. THIS INCIDENT INVOLVED A BRIEF SURGICAL INTERRUPTION WITH SIGNIFICANT RISKS, SO IT IS CLASSIFIED AS SEVERE. ADDITIONAL INFORMATION RECEIVED: THE ENDOSCOPE SCREEN FLICKERED MOMENTARILY DURING SURGERY, THEN RETURNED TO NORMAL IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH THIS ENDOSCOPE WITHOUT SIGNIFICANT DELAY, ONLY LASTING A FEW SECONDS.

Additional Manufacturer Narrative

UNDER USER'S DISCRETION THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE, INVESTIGATION RESULTS ARE PENDING.THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (b)(4).