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

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS 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, SINCE IT IS CLEARLY STATED AS A CAUTION NOTE IN THE INSTRUCTIONS FOR USE THAT THE CONNECTORS OF THE ENDOSCOPIC EQUIPMENT AND THE DISTAL END OF THE ENDOSCOPE BECOME HOT AND THAT THERE IS A RISK OF BURNS IF THE EQUIPMENT IS PLACED ON THE PATIENT¿S SKIN, THIS INCIDENT WAS ATTRIBUTED TO USE ERROR. FURTHERMORE, A DHR REVIEW COULD NOT BE PERFORMED SINCE BASIC DATA OF ARTICLE IDENTIFICATION (LOT NUMBER) ARE MISSING. INSTEAD A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE LAST 24 MONTHS OF PRODUCTION. THERE WERE NO NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. 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 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 TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE THE PATIENT SUSTAINED A BURN INJURY WHEN THE ACTIVATED WA03310A LIGHT-GUIDE CABLE WAS PLACED ON THE PATIENT¿S ABDOMEN WITH NO TELESCOPE CONNECTED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE OLYMPUS MEDICAL DEVICES.