TRIVEX SYSTEM RESECTOR HANDPIECE
Received Oct 28, 2018 · Event occurred Sep 21, 2018
Report 1220948-2018-00089 · MDR key 8011462
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 RECEIVED THE DEVICE FOR EVALUATION. THE MDU HOUSING WAS VISUALLY INSPECTED AND WAS FOUND TO BE ACCEPTABLE. UPON FURTHER INSPECTION OF THE CONNECTOR OF THE HANDPIECE AND THE POWER CABLE, WE OBSERVED RUST WHICH SUGGESTS PRESENCE OF MOISTURE INSIDE THE CONNECTOR. THE DRIVE SHAFT ROTATED PROPERLY ON ALL SETTINGS AND SPEEDS. UPON DISASSEMBLY OF THE HOUSING, WE OBSERVED WATER INSIDE THE CORE TUBE AND UNDER THE PC BOARD. THE HEAT SINK WAS OBSERVED TO HAVE STUCK TOGETHER WITH THE CORE TUBE DUE TO CORROSION. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE DAMAGE TO INNER COMPONENTS OF THE HANDPIECE DUE TO WATER INGRESS. IT IS POSSIBLE THAT THE DEVICE HANDLING TECHNIQUE AND IMPROPER STERILIZATION PROCESS AT THE HOSPITAL COULD HAVE CONTRIBUTED TO THIS INCIDENT. OUR IFU CLEARLY STATES NOT TO REMOVE THE CABLE FROM THE HANDPIECE AND SECURE THE CABLE END WITH THE PROTECTIVE CAP DURING STERILIZATION. WE CURRENTLY ALSO HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.
Description of Event or Problem
THE HANDPIECE FAILED TO OPERATE DURING THE PROCEDURE.