TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Received Feb 7, 2019 · Event occurred Oct 17, 2018
Report 1220948-2019-00010 · MDR key 8318309
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO REPLICATE THE REPORTED DEFECT DURING OUR EVALUATION. THE CONTROL UNIT WAS FOUND TO BE FUNCTIONING PROPERLY AT ALL SETTINGS AND SPEEDS. THE CONTROL UNIT WAS TESTED MULTIPLE TIMES BUT WE DID NOT OBSERVE ANY FAILURE WITH THE CONTROL UNIT. DURING THE PROCEDURE AT THE HOSPITAL, THE INDICATOR LIGHT ON THE CONTROL UNIT PROPERLY FLASHED ORANGE INDICATING AN ISSUE WITH THE HANDPIECE. THE SURGEON THEN EXCHANGED THE HANDPIECE AND THEN INCREASED THE RPM ON THIS CONTROL UNIT WHICH RESOLVED THIS ISSUE. WE HAVE SUBSEQUENTLY EVALUATED THREE HANDPIECES THAT WERE RETURNED FROM THIS HOSPITAL THAT MAY HAVE BEEN USED IN THIS CASE. OUR EVALUATION FOUND TWO OF THE THREE HANDPIECES WERE OPERATING INTERMITTENTLY. IT IS POSSIBLE THAT A FAULTY HANDPIECE LED TO THIS INCIDENT RATHER THAN THE CONTROL UNIT WHICH WAS EVALUATED TO BE FULLY FUNCTIONAL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.
Description of Event or Problem
DURING TRANSILLUMINATED POWERED PHLEBECTOMY (TIPP), THE CONTROL UNIT STOPPED WORKING PERIODICALLY FLASHING ORANGE LIGHT ON THE CONTROL UNIT.