0.035" HYBRID WIRE, BOX OF 5
Received Aug 24, 2022 · Event occurred Jul 23, 2020
Report 3003790304-2022-00170 · MDR key 15284795
Device
Product problems
- Material Frayed
- Material Frayed
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE EXTERNAL PART OF THE GUIDEWIRE WAS FRAYED. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR A RETROGRADE INTRARENAL SURGERY, WHICH WAS COMPLETED WITH A NEW WIRE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
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 RETURNED TO OLYMPUS FOR EVALUATION WHERE SERVICE CONFIRMED THE CUSTOMER'S COMPLAINT, THE GUIDEWIRE WAS UNRAVELING 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 INVESTIGATION, IT IS LIKELY THAT THE CAUSES ARE MANUFACTURING ERROR OR A USER ERROR. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.