VIPER

Additional Manufacturer Narrative

THERE HAS BEEN NO REPORT OF INJURY TO THE PATIENT. THE REPORTED ISSUE DID NOT CAUSE ANY CRITICAL DELAY OR POSE ANY UNACCEPTABLE RISK. HOWEVER, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) HAS SUBMITTED A COMPARABLE REPORTABLE SERIOUS INCIDENT IN THE PAST TWO YEARS AND THEREFORE HAVE CONSIDERED TO REPORT THIS CASE TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CYSTOSCOPY WITH LASER LITHOTRIPSY, THE COATING AT THE TIP OF THE SCOPE IS BUNCHED UP.