WM-NP2 WORKSTATION SET 3 (ROW)
Received Mar 13, 2025 · Event occurred Mar 4, 2025
Report 9611174-2025-00094 · MDR key 21594158
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10020681Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THAT THE SUBJECT DEVICE HAD A BROKEN CASTER. THIS WAS DISCOVERED DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
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, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION 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: COMPONENT FAILURE OF THE CASTOR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.