TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 23, 2018 · Event occurred Jan 24, 2018
Report 1220948-2018-00009 · MDR key 7293171
Device
Product problems
- Device Inoperable
- Device Inoperable
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE INVESTIGATION IS ONGOING. DEVICE WAS SOLD TO THE HOSPITAL ON (B)(6) 2014. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT. HOWEVER, IT IS POSSIBLE THAT THE DEVICE FAILED DUE TO WATER INGRESS WHICH COULD OCCUR DUE TO EXCESSIVE WEAR FROM REPEATED CLEANING, USE AND STERILIZATION. PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS INCIDENT.
Description of Event or Problem
OPERATOR EXPERIENCED DIFFICULTY WHEN INSERTING THE RESECTOR BLADES INTO THE HANDPIECE PRIOR TO THE PROCEDURE. THE DEVICE STOPPED WORKING DURING THE PROCEDURE. DEVICE WAS NOT IN CONTACT WITH THE PATIENT WHEN THE MALFUNCTION OCCURRED.