HF-RESECTION ELECTRODE "PLASMALOOP MEDIUM, LOOP, 24 FR., STANDARD,

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: LOT NUMBER, EXPIRATION DATE; DEVICE MANUFACTURER DATE DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT¿S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE OLYMPUS MEDICAL DEVICES USED DURING THE PROCEDURE AND BASED ON THE CUSTOMER¿S DESCRIPTION IT CAN BE ASSUMED THAT NONE OF THE OLYMPUS DEVICES CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE HF RESECTION ELECTRODE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION IN SALINE (TCRIS) PROCEDURE, THE PATIENT SUSTAINED AN INTESTINAL PERFORATION. THE INTENDED PROCEDURE WAS THEN SWITCHED TO OPEN SURGERY TO TREAT THE PERFORATION. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE OLYMPUS MEDICAL DEVICES.