WM-NP2 WORKSTATION SET 1 (US)
Received Mar 18, 2025
Report 9611174-2025-00097 · MDR key 21636819
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021764Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 SUBJECT DEVICE EXHIBITED FRACTURED FRONT RIGHT WHEEL. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D9, G3, G6, H2, H3, H6 AND H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.