WM-NP2 WORKSTATION SET 1 (JP)
Received May 21, 2026
Report 9611174-2026-00103 · MDR key 25244215
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021766Product problems
- Break
Patient
NA · Unknown
- 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: B5, D8, H2, H3, H6 AND H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED MALFUNCTION BROKEN CASTER COULD NOT BE ESTABLISHED. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE WORKSTATION MODEL PLATFORM 2 SERIES OF ENDOSCOPY WORKSTATIONS HAD A BROKEN CASTER. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.