EASYSUITE 4K INTEGRATION SYS MODEL 1200
Received May 6, 2024
Report 3011050570-2024-00162 · MDR key 19255745
Device
Product problems
- No Device Output
- No Device Output
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED, THE DIGITAL IMAGE STORAGE HAD NO IMAGES ON THE MONITORS AND THE MOUSE WAS NOT WORKING ON THIS SYSTEM. THE ISSUE WAS DISCOVERED BEFORE AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE DEVICE WAS EXAMINED ONSITE AND THE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS TO PROVIDE A CORRECTION TO THE INITIAL MEDWATCH REPORT (MDR). THE INITIAL MEDWATCH REPORTED THE DIGITAL IMAGE STORAGE HAD NO IMAGES ON THE MONITORS AND THE MOUSE WAS NOT WORKING ON THIS SYSTEM. PER THE LEGAL MANUFACTURER, THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE THE ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.