TM-400
Received Jan 18, 2017 · Event occurred Mar 14, 2016
Report 9614750-2017-00003 · MDR key 6261009
Device
Product problems
- Difficult to Remove
- Sticking
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
- No Known Impact Or Consequence To Patient
- No Patient Involvement
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE WAS DISCARDED AT THE EVENT SITE. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
DURING A PROCEDURE, THE TRACTION ROPE OF THE SUBJECT TM-400 DEVICE GOT STUCK. EVEN AFTER WAITING A WHILE TO TRY TO PULL OUT THE ROPE, THE ROPE WAS STILL STUCK AND COULD NOT BE PULLED OUT. AFTER TURNING OFF THE POWER AND TRYING TO RESUME THE PROCEDURE, THE ROPE COULD BE REELED UP AND A SMOOTH TRACTION WAS RESUMED. WHEN THE TRACTION POWER LEVEL WAS SET FROM 0 TO 60%, THE ROPE GOT STUCK INSTANTANEOUSLY AND THEN STARTED TRACTION WITH A HIGH SPEED (A SPEED OF 60 TO 100% TRACTION POWER). WHEN THE 90KG SETTING WAS SELECTED, THE ROPE BECAME STUCK WITHOUT EXCEPTION.
Additional Manufacturer Narrative
ITO EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT TM-400 DEVICE. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THE USER FACILITY DID NOT DISCLOSE THE PATIENT'S INFORMATION.