COMPLAINT DESCRIPTION: THE HOSPITAL REPORTED 9 PATIENT BRONCHIAL LAVAGE SAMPLES SHOWED "CLUSTERS" OF CLADOSPORIUM FUNGUS CONTAMINATION. OF THE 9 PATIENTS, HALF OF THE PATIENT HAD UNDERGONE PROCEDURES WITH THE SAME ENDOSCOPE. THE HOSPITAL REPORTED THEY FOUND A HOLE IN THE INSTRUMENT CHANNEL THAT THEY HAD PREVIOUSLY MISSED DURING LEAK TESTING DUE TO A FAULTY LEAK TESTER. THE HOSPITAL REPORTED THAT THEY COULD NOT DIRECTLY LINK THE ENDOSCOPE TO PATIENT INFECTION BECAUSE THE PATIENTS HAD ALREADY BEEN INFECTED BEFORE THE PROCEDURES WERE PERFORMED. THE PATIENTS WERE TREATED FOR THE INFECTIONS THAT HAD INITIALLY PROMPTED THEIR PROCEDURES, AND ALL ARE REPORTEDLY DOING FINE.
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Patient 1
INVESTIGATION ANALYSIS: THE SCOPE WAS STERILIZED BY ETO AND SENT TO OLYMPUS FOR TECHNICAL INVESTIGATION. THE INVESTIGATION REVEALED A BUILD UP OF A YELLOWISH/REDDISH STAIN ON THE K-MOUNT UNIT WALL AT THE BODY CONTROL UNIT. IN ADDITION, THE INSTRUMENT CHANNEL OF THE ENDOSCOPE WAS FOUND LEAKING WITH EXCESSIVE TEARS MARKS AT APPROXIMATELY 1CM FROM THE DISTAL END DUE TO PHYSICAL DAMAGE. AS A RESULT OF THE DAMAGED CHANNEL, FLUID INVADED THE SCOPE AND CAUSED HEAVY CORROSION IN THE BODY CONTROL UNIT. THE UP/DOWN CONTROL KNOB WAS FROZEN DUE TO THE CORROSION. OLYMPUS CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. HOWEVER, THE PHYSICAL CONDITION OF THE SCOPE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.