TC-E410 CART 110-120V US SET 1
Received Oct 22, 2024
Report 9611174-2024-00042 · MDR key 20509356
Device
Generic name
Endoscopy Workstation
Manufacturer
Keymed (medical And Industrial Equipment) LtdModel number
K10030282Product 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 DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, IT WAS PRESUMED THAT THE CAUSE OF THE FAILURE WAS DUE TO METAL FATIGUE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPY WORKSTATION EXHIBITED A BROKEN CASTOR DUE TO MULTIPLE IMPACTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.