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

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: LIGHT PROJECTORS EMIT A LARGE AMOUNT OF ENERGY, WHICH CAUSES THE CONNECTIONS OF THE LIGHT GUIDE CABLE AS WELL AS THE CONNECTION AND THE DISTAL END OF THE OPTICS TO HEAT UP CONSIDERABLY. THIS CAN LEAD, FOR EXAMPLE, TO THE MELTING OF HEAT-SENSITIVE OBJECTS OR EVEN TO SKIN BURNS IF THE ENDOSCOPIC EQUIPMENT IS PLACED ON A HEAT-SENSITIVE OBJECT OR A PATIENT IMMEDIATELY AFTER USE OR, WORSE STILL, WHILE LIGHT IS STILL BEING EMITTED. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): IN THE IFU INFORMATION IS PROVIDED TO USE THE PRODUCTS CORRECTLY AND WITH CAUTION, E.G.: CAUTION ADVICE NOT TO PLACE ENDOSCOPIC EQUIPMENT ON PATIENT SKIN OR FLAMMABLE/HEAT-SENSITIVE MATERIALS AN INSPECTION OF THE PRODUCTS BEFORE EACH USE IS DESCRIBED IN THE IFU, SUCH A DEFECT THEREFORE SHOULD BE DISCOVERED BEFORE USE. A REPLACEMENT OF DEFECT DEVICES AND CONTACT TO OLYMPUS REPRESENTATIVES IS SUGGESTED. CAUTION ADVICE THAT LIGHT EMISSION PART/DISTAL END & CONNECTORS GET HOT. CAUTION ADVICE TO SET OUTPUT POWER OF SUPPLY UNIT AS TO THE MINIMUM LEVEL THAT IS NEEDED FOR A SUFFICIENT ILLUMINATION. CAUTION ADVICE TO SWITCH SUPPLY UNIT OFF IF NOT USED¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE LIGHT GUIDE CABLE WAS PLACED ON TOP OF A DRAPE DURING TREATMENT, THE DRAPE MELTED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.