WM-NP2 WORKSTATION SET 1 (JP)
Received Jul 22, 2025 · Event occurred Jun 23, 2025
Report 9611174-2025-00227 · MDR key 22564786
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021766Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO NEW ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE WORKSTATION HAD SMOKE COMING FROM THE TROLLEY OUTLET DURING AN UPPER ENDOSCOPY, WHICH WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.