WM-NP2 WORKSTATION SET 1 (JP)
Received Feb 5, 2026 · Event occurred Oct 9, 2025
Report 9611174-2026-00035 · MDR key 24272236
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
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE ALLEGED MALFUNCTION WAS CAUSED BY A COMPONENT FAILURE OF THE CASTER. 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
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPY WORKSTATION EXHIBITED A DAMAGED AND BROKEN CASTER. THERE WAS NO PATIENT INVOLVEMENT.