GYRUS, PK-SP GENERATOR
Received Aug 4, 2022 · Event occurred Nov 17, 2021
Report 3003790304-2022-00149 · MDR key 15165303
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. 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, THE SUPPORT LINE TECHNICIAN INFORMED THE CUSTOMER THAT THE ELECTRODE TIP MUST BE SUBMERGED IN A SALINE SOLUTION BEFORE BEING OPERATED. THE CUSTOMER DID THIS AND THE UNIT WAS OPERATING PROPERLY AT THE END OF THE CALL AND THE UNIT WAS NOT RETURNED. THE CAUSE OF THE ERROR WAS THE LACK OF THE SALINE SOLUTION. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS DISPLAYING A CHECK IRRIGANT ELECTRODE ERROR. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.