WM-NP3 MOBILE WORKSTATION EU URO
Received Oct 20, 2025 · Event occurred Jun 30, 2025
Report 9611174-2025-00334 · MDR key 23343635
Device
Generic name
Wm-*p3 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10035370Product problems
- Melted
- Moisture Damage
- Smoking
- Electrical Shorting
- Unexpected Shutdown
- Melted
- Moisture Damage
- Smoking
- Electrical Shorting
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H4, H6 AND H11. THE DEVICE WAS NOT RETURNED TO THE REGIONAL SERVICE CENTER FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
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 WORKSTATION HAD SMOKE AND SPARK WHEN IT WAS POWERED ON, DURING SET-UP/INSPECTION FOR USE. IT WAS WET BOTH INSIDE AND OUTSIDE AS THE SOLUTION FLOWED TO THE DEVICE FROM AN INCORRECTLY INSTALLED DOSING TUBE OF THE IRRIGATION PUMP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.