WM-NP2 WORKSTATION SET 3 (EU)
Received Feb 28, 2025 · Event occurred Feb 5, 2025
Report 9611174-2025-00063 · MDR key 21488036
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021964Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN WHEELS ON TROLLEY MAKING IT VERY DIFFICULT TO MOVE TROLLEY BETWEEN ROOMS. THE EVENT OCCURRED DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
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
NO ADDITION INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, H6, H11. THE DEVICE WAS INSPECTED FOR THE FIELD SERVICE ENGINEER (FSE) OF OLYMPUS AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: BROKEN WHEELS ON TROLLEY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.