MalfunctionGIE
MULTIDEBRIDER POWER CONSOLE
Received Aug 12, 2020
Report 1037007-2020-00033 · MDR key 10397478
Device
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE DEVICE EXHIBITED ERROR 12 ERROR MESSAGE. ACCORDING TO THE REPORTER, THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO ANOTHER SIMILAR DEVICE. TYPE OF PROCEDURE, SERIAL NUMBER OF THE DEVICE USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT.