TRIVEX SYSTEM CONTROL UNIT
Received Feb 28, 2019 · Event occurred Jan 29, 2019
Report 1220948-2019-00019 · MDR key 8379891
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL AT THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. WE HAVE REQUESTED THE CONTACT PERSON AT THE HOSPITAL FOR ADDITIONAL INFORMATION. HOWEVER, WE DID NOT GET ANY RESPONSE BACK FROM THE CONTACT PERSON. THERE HAS BEEN NO SERIOUS INJURY NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR SINCE THE CONTROL UNIT COULD NOT BE USED FOR THE PROCEDURE. HOWEVER, WE HAVE DECIDED TO REPORT THE INCIDENT SINCE OUR EVALUATION WAS BASED ON THE REPORTED DEFECT FROM OUR SALES REP. AND THE USER AT THE HOSPITAL RATHER THAN OUR HANDS-ON EVALUATION WITH THIS DEFECTIVE DEVICE ITSELF.
Description of Event or Problem
THE CONNECTOR IN THE CONTROL UNIT WAS LOOSE AND WAS NOT CONNECTING PROPERLY INTO THE HANDPIECE CABLE.