WM-NP2 WORKSTATION SET 1 (JP)
Received Oct 9, 2025 · Event occurred Sep 12, 2025
Report 9611174-2025-00320 · MDR key 23260735
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021766Product problems
- Mechanical Problem
- Mechanical Problem
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. THE SUBJECT DEVICE WILL NOT BE SENT BACK TO OLYMPUS FOR FURTHER EVALUATION AND REPAIR. THE CASTOR WAS REPLACED ONSITE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, 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 SUBJECT DEVICE EXHIBITED THAT CASTER WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.