ENDOSCOPE POSITION DETECTING UNIT

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION, AN OLYMPUS FIELD SERVICE ENGINEER WHO INSPECTED THE SUBJECT DEVICE ON-SITE FOUND THAT THERE WAS NO PROBLEM WITH THE SCOPE GUIDE; HOWEVER, THE CABLE WAS DEFECTIVE AND NEEDED TO BE REPLACED. A ROOT CAUSE FOR THE CABLE FAILURE COULD NOT BE DETERMINED.

Description of Event or Problem

THE FIELD SERVICE COORDINATOR ON BEHALF OF THE CUSTOMER REPORTED, THE ENDOSCOPE POSITION DETECTING UNIT WAS NOT WORKING DURING A COLONOSCOPY DUE TO WHICH THE PROCEDURE HAD TO BE CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS AVAILABLE.