WM-NP2 WORKSTATION SET 6 (EU)
Received Aug 13, 2025
Report 9611174-2025-00252 · MDR key 22794856
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021617Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H3, H4, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION. HOWEVER, THE DEVICE WAS EVALUATED BY A FIELD SERVICE ENGINEER AND THE CUSTOMER'S MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE EVENT WAS LIKELY CAUSED BY THE SHORT-CIRCUITED AND NON-FUNCTIONAL TRANSFORMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE SUBJECT DEVICE PRESENTED A SHORT CIRCUIT EPISODE WITH THE SMELL OF BURNING DURING SETUP/INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.