TRIVEX SYSTEM RESECTOR HANDPIECE
Received Jul 28, 2017 · Event occurred Jun 19, 2017
Report 1220948-2017-00043 · MDR key 6751868
Device
Product problems
- Device Inoperable
- Device Inoperable
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
OUR INVESTIGATION OF THE COMPLAINT DEVICE HAD CONFIRMED THE REPORTED INCIDENT. WE FOUND THAT THE MOTOR AND THE SEAL HOUSING ASSEMBLY HAD CORRODED TO THE CORE TUBE. THE DRIVE SHAFT ROTATED FREELY BY HAND SUGGESTING A MOTOR MALFUNCTION. SEPARATING MOTOR FROM SEAL HOUSING FOR A NO LOAD TEST PRODUCED SIMILAR FAILURE. IT IS LIKELY THE FAILURE OF THE DC MOTOR IS RELATED TO THE INTERNAL LOGIC MALFUNCTION. THIS IS A MULTI-USE DEVICE AND BE REUSED FOR THE PHLEBECTOMY PROCEDURE AFTER STERILIZATION. WATER COULD SOMETIME PENETRATE INTO THE HANDPIECE DURING THE CLEANING AND THE STEAM STERILIZATION AND AS A RESULT COULD CORRODE THE MOTOR AND BEARING. WE HAVE CHANGED THE PLASTIC MATERIAL OF THE BEARING THUS PROVIDING IMPROVED STRENGTH, LUBRICITY, TEMPERATURE AND CHEMICAL RESISTANCE AND IMPROVED STABILITY. THIS UNIT WAS MANUFACTURED PRIOR TO THESE CHANGES BEING IMPLEMENTED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.
Description of Event or Problem
DURING PHLEBECTOMY, RESECTOR STOPPED WORKING.