LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE 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 TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE PATIENT SUSTAINED A BURN ON THE INNER THIGH WHICH REQUIRED FURTHER TREATMENT. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE MEDICAL DEVICES. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE INVESTIGATION/EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE LIGHT-GUIDE CABLE. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. FURTHERMORE, A MANUFACTURING AND QUALITY CONTROL REVIEW COULD NOT BE PERFORMED SINCE BASIC DATA OF ARTICLE IDENTIFICATION (LOT NUMBER) ARE MISSING. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.