OLYMPUS WAS INFORMED THAT DURING THE ENDOSCOPIC REMOVAL OF THE CEREBRAL HEMATOMA, THE FACILITY HAD CONNECTED THE CH-S190-XZ-E TO THE VIDEO PROCESSOR OTV-S190, THE ERROR B30 (INDICATING THE OTV-S190 COULD NOT COMMUNICATE WITH THE CH-S190-XZ-E) HAD BEEN DISPLAYED ON THE MONITOR. THE FACILITY HAD DETACHED THE CH-S190-XZ-E FROM THE OTV-S190 AND WIPED THE SURFACE OF THE CONNECTOR OF THE CH-S190-XZ-E. THEN THE FACILITY HAD RECONNECTED THE CH-S190-XZ-E TO THE OTV-S190, HOWEVER THE ERROR B30 HAD BEEN DISPLAYED ON THE MONITOR AGAIN. THE FACILITY HAD COMPLETED THE PROCEDURE WITH USE OF THE OTHER CH-S190-XZ-E. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.
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Patient 1
THE REFERENCED CH-S190-XZ-E WAS RETURNED TO THE OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT, HOWEVER COULD NOT IDENTIFY THE CAUSE OF THIS PHENOMENON. THERE WAS NO ABNORMALITY AND/OR IRREGULARITY OF THE EXTERIOR OF THE DEVICE. ALSO, OMSC CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT CH-S190-XZ-E, THERE WAS NO IRREGULARITY FOUND. OMSC STATED THE APPROPRIATE HANDLING OF THE CH-S190-XZ-E IN THE INSTRUCTION MANUAL WHEN THE CH-S190-XZ-E HAD ABNORMALITIES. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.