WM-NP2 WORKSTATION SET 4 (JP)
Received Oct 9, 2025 · Event occurred Sep 11, 2025
Report 9611174-2025-00317 · MDR key 23257571
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 NOT RETURNED TO OLYMPUS FOR INSPECTION. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY AND CONFIRMED THE REPORTED ISSUE. CASTOR WAS FOUND TO BE BROKEN. THE SUBJECT DEVICE WILL NOT BE SENT BACK TO OLYMPUS FOR FURTHER EVALUATION AND REPAIR. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION THE ISSUE WAS CAUSED BY A COMPONENT FAILURE OF THE CASTER. 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 CASTOR WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.