WM-NP2 WORKSTATION SET 4 (JP)
Received Oct 17, 2025 · Event occurred Sep 18, 2025
Report 9611174-2025-00331 · MDR key 23322158
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021610Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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: CASTER WAS FOUND TO BE BROKEN. COMPONENT FAILURE OF THE CASTER. THIS EVENT IS CAUSED BY A COMPONENT FAILURE OF THE CASTER. THE CAUSE OF THE CASTER FAILURE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 SUBJECT DEVICE EXHIBITED CASTER WAS FOUND TO BE BROKEN, COMPONENT FAILURE OF THE CASTER. THERE WAS NO PATIENT INVOLVEMENT.