HF UNIT "ESG-400"
Received Jan 18, 2023 · Event occurred Dec 19, 2022
Report 9610773-2023-00263 · MDR key 16199940
Device
Product problems
- Device Alarm System
- Device Alarm System
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS. NO ABNORMALITY WAS FOUND ON THE APPEARANCE OR INTERNAL PART OF THE DEVICE. TROUBLESHOOTING WAS PERFORMED AFTER REPLACING A SPARE HVPS BOARD. 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 ISSUE OCCURRED DUE TO A FAULTY HIGH VOLTAGE POWER SUPPLY (HVPS) BOARD. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED TO OLYMPUS THAT AN HF UNIT HAD AN ABNORMAL SOUND AND ERROR E433 WHEN THE MACHINE WAS TURNED ON. THE ISSUE WAS FOUND DURING PREPARATION (PATIENTS WERE NOT ANESTHETIZED) BEFORE THE USE OF ELECTROSCOPIC SURGERY. USER FINISHED CASE WITH ANOTHER DEVICE, AND IT WAS NOT DELAYED MORE THAN 15 MINUTES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.