FUSION

Additional Manufacturer Narrative

SINCE THE INSTRUMENTS/DEVICES ARE NOT BEING SENT IN FOR EXAMINATION, RICHARD WOLF GMBH CAN ONLY SPECULATE ON THE FOLLOWING CAUSES FOR THE HEAT: SINCE THE 5MM DIAMETER FUSION LIGHT FIBER CABLE WAS USED IN CONJUNCTION WITH THE URETERO-RENOSCOPE, FOR WHICH THE USE OF A 2.5 MM OR 2.3 MM DIAMETER LIGHT FIBER CABLE IS MANDATORY (THIS INFORMATION IS DESCRIBED IN THE INSTRUCTIONS FOR USE, GA-D 352 MANUAL, AND THERE ARE ALSO WARNINGS ABOUT BURNS AND EXCESSIVE TEMPERATURE). THE HIGH INTENSITY OF THE EMITTED LIGHT CAN LEAD TO THE FOLLOWING: IF THE LIGHT GUIDE AND ENDOSCOPE ARE INCORRECTLY COMBINED, THE ENDOSCOPE ADAPTER BECOMES VERY HOT; IF THE ENDOSCOPE IS NOT CONNECTED BUT THE LIGHT IS TURNED ON, THE ADAPTER BECOMES VERY HOT; OR IF THE DISTANCE BETWEEN THE TISSUE AND THE END FACE OF THE LIGHT GUIDE CABLE IS VERY SMALL, BURNS MAY OCCUR. THESE POINTS ARE DESCRIBED IN VARIOUS USER MANUALS (FIBER-OPTIC CABLE/(LIGHT SOURCE)) AND, IN OUR VIEW, CONSTITUTE USER ERROR. 8.2 FUNCTION CHECK: DISCONNECT THE PRODUCT FROM THE LIGHT SOURCE AND CARRY OUT THE FOLLOWING FUNCTION CHECKS: 1. CHECK FOR SECURE CONNECTIONS. 2. CHECK THE LOCKING MECHANISM OF THE ENDOSCOPE-SIDE ADAPTER. REPLACE THE ADAPTER IF THE CONNECTION: ALTHOUGH LOCKED, IS NOT SECURE, CANNOT BE LOCKED OR IS DIFFICULT TO LOCK. 3. CHECK THE GLASS SURFACES FOR ANY DEPOSITS. DEPOSITS ON THE GLASS SURFACES CAN CAUSE A SPOTTED OR BLURRED FIELD OF VIEW AND HENCE IMPAIR LIGHT TRANSMISSION CONSIDERABLY. THIS WILL CAUSE INCREASED HEAT AT THE CONNECTORS AND CAN LEAD TO BURNS OR FAILURE OF THE LIGHT CABLE. 9.1.2 IDENTIFICATION OF FIBER BUNDLE DIAMETER ON FIBER LIGHT CABLE. CAUTION: INTENSE HEAT DUE TO HIGH LIGHT ENERGY! UNFAVORABLE CONDITIONS CAN CAUSE AN INCREASE IN TEMPERATURE AT THE COUPLING POINT OF THE FIBER LIGHT CABLE AND THE LIGHT EXIT OF THE ENDOSCOPE. BURNS ON THE PATIENT, USER AND OTHERS AS WELL AS DAMAGE TO ENDOSCOPE ARE POSSIBLE. REDUCE THE LIGHT OUTPUT OR CHOOSE A FIBER LIGHT CABLE WITH SUITABLE DIAMETER. 9.2.2 LIGHT: DANGER OF BURNS! DUE TO THE HIGH ENERGY OF THE LIGHT SOURCE, THE ADAPTER AND GLASS SURFACES ON THE FIBER LIGHT CABLE ARE EXTREMELY HOT WHEN DISCONNECTED FROM THE LIGHT SOURCE. THIS MAY CAUSE BURNS IF INADVERTENTLY THE PATIENT, USER OR OTHERS TOUCH THE PARTS. DO NOT TOUCH THE ADAPTER OR THE GLASS SURFACE OF THE FIBER LIGHT CABLE. ALLOW THE FIBER LIGHT CABLE TO COOL DOWN. IN SUMMARY: THIS INAPPROPRIATE COMBINATION MAY HAVE CAUSED EXCESSIVE HEATING AT THE CONNECTION POINT BETWEEN THE PRODUCTS. AS OF NOW, WE CANNOT SEE HOW THE TIP OF THE LIGHT GUIDE COULD COME INTO CONTACT WITH THE PATIENT, LET ALONE BURN THEM, IF THE DEVICE IS BEING USED AS INTENDED. IN RICHARD WOLF GMBH RISK ANALYSIS F3-1 REV. V00, HAZARDS RELATED TO HANDLING, MANUFACTURING, AND DESIGN INCLUDING THOSE INVOLVING FUNCTIONAL IMPAIRMENT AS WELL AS RISKS ARISING FROM A PRODUCT THAT CANNOT BE USED, ALONG WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE, WERE CONSIDERED AND ASSESSED AS AN ACCEPTABLE RISK.

Description of Event or Problem

THE USER REPORTED THAT, THE PRODUCT BECAME EXCESSIVELY HOT, CAUSING A THIRD-DEGREE THERMAL BURN TO THE PATIENT'S GLANS. AFTER THE PROCEDURE WAS COMPLETED, THE DOCTOR LEFT THE URETERO-RENOSCOPE ON THE PATIENT WHILE THE ENDOLIGHT LED 2.2 REMAINED TURNED ON, WITH THE LIGHT FIBER CABLE AND THE URETERO-RENOSCOPE STILL CONNECTED, CONTRIBUTING TO THE REPORTED INCIDENT.