OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC, THE EXACT CAUSE WAS UNKNOWN. OMSC SURMISED THAT THE REPORTED PHENOMENON OCCURRED DUE TO PHYSICAL STRESS AND OTHER ON THE INSERTION TUBE.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS LOCAL SERVICE DEPARTMENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT THE OLYMPUS LOCAL SERVICE DEPARTMENT, IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE OF THE SUBJECT DEVICE HAD BEEN PARTIALLY PEELED OFF. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.