WM-NP2 WORKSTATION SET 4 (JP)
Received Mar 19, 2024 · Event occurred Mar 12, 2024
Report 9611174-2024-00018 · MDR key 18933896
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) LtdModel number
K10021610Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT D9. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE COULD NOT BE IDENTIFIED ALTHOUGH IT CAN BE PRESUMED THAT IT WAS CAUSED BY BRITTLE FRACTURE DUE TO METAL FATIGUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
(B)(6) MEDICAL CENTER TO DATE, THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED, THE WM-NP2 WORKSTATION SET 4 (JP) EXHIBITED A BROKEN REAR CASTER CAUSING THE ENTIRE TROLLEY TO FALL OVER. THERE WERE NO REPORTS OF PATIENT HARM.