LIGHT-GUIDE CABLE, 2.8 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 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 TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PATIENT SUSTAINED A BURN INJURY OF AN UNKNOWN DEGREE IN THE RIGHT ABDOMEN AND INGUINAL REGION RESULTING FROM THE SHEET COVERING THE PATIENT WHICH CAUGHT FIRE. HOWEVER, IT IS UNCLEAR WHETHER THE INJURY WAS CAUSED BY A MALFUNCTION OF ANY OF THE OLYMPUS DEVICES. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.

Additional Manufacturer Narrative

DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4)(RETURNED TO OMSC ON 2019-06-24). DURING THE EVALUATION/INVESTIGATION OF THE LIGHT-GUIDE CABLE NO VISIBLE OR FUNCTIONAL NONCONFORMITIES WERE DETECTED. THE DEVICE WAS FOUND TO BE IN STANDARD. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. 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 LIGHT-GUIDE CABLE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.