SINGLE USE RETRIEVAL BASKET V

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE EVENT TYPE AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED ALLEGATION COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

Description of Event or Problem

IT WAS REPORTED THERE WAS AN EXTENSION OF THE PROCEDURE GREATER THAN 30 MINUTES.

Description of Event or Problem

IT WAS REPORTED THE SINGLE USE RETRIEVAL BASKET'S WIRE IN THE SPIRAL TUBE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, DURING SEDATION AND WHILE THE DEVICE WAS INSIDE THE PATIENT. THE BROKEN TUBE WAS REMOVED BY HAND. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT 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.