0.035" HYBRID WIRE, BOX OF 5

Additional Manufacturer Narrative

THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. THE DHR WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT A COOK MEDICAL URETERAL STINT MALFUNCTIONED WHEN USING THE OLYMPUS GUIDE WIRE . THE REPORTED PROBLEM WAS FOUND DURING A THERAPEUTIC URETEROSCOPY, WHICH WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.