SINGLE USE RETRIEVAL BASKET V

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, CORRECTED INFORMATION IN D4 AND ADDITIONAL INFORMATION IN D8, D9, D10, H3, H4 AND H6. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: SOME FORCE BEYOND THE ADHESIVE STRENGTH WAS APPLIED TO THE GUIDEWIRE TIP DURING THE PROCEDURE. THIS MIGHT HAVE CAUSED THE ADHESION PEELING BETWEEN THE GUIDEWIRE TIP AND THE DISTAL TIP. AS A RESULT, THE GUIDEWIRE TIP CAME OFF. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE GUIDE WIRE TIP CAME LOOSE IN THE COMMON BILE DUCT, BUT WAS POSSIBLE TO BE RETRIEVED DESPITE THE STONE BEING SOFT. THIS EVENT OCCURRED DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PROCEDURE WAS PROLONGED FOR LESS THAN 30 MINUTES AND COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.