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

Additional Manufacturer Narrative

DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THE EVALUATION SHOWED THAT THE CAUSE FOR THIS ISSUE IS MOST LIKELY IMPROPER HANDLING. THERE ARE CAUTION NOTES IN THE INSTRUCTIONS FOR USE, WHICH CLEARLY STATE THAT LIGHT-GUIDE CABLE CONNECTORS MAY BECOME HOT AND SHOULD NOT BE PLACED ON THE PATIENT¿S SKIN, ON FLAMMABLE MATERIALS, OR ON HEAT-SENSITIVE MATERIALS. HENCE THE REPORTED PHENOMENON DOES NOT REPRESENT A MALFUNCTION. 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 BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

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 PRIOR TO A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE LINER CLOTH CAUGHT FIRE AFTER THE LIGHT-GUIDE CABLE WAS CONNECTED TO THE LIGHT SOURCE. FOR FIVE TO TEN MINUTES THE LIGHT SOURCE WAS IN STANDBY MODE AND THE LIGHT-GUIDE CABLE WAS NOT CONNECTED TO THE RIGID SCOPE. THE FIRE OF THE LINER CLOTH CAUSED A THIRD-DEGREE BURN CLOSE TO THE PATIENT¿S WAIST. AN INCISION WAS MADE TO REMOVE THE DEAD SKIN AND THE WOUND WAS SUTURED AFTERWARDS TO CLOSE IT. NO FURTHER INFORMATION WAS PROVIDED, BUT THE INTENDED PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT.