TRIVEX SYSTEM RESECTOR HANDPIECE
Received Dec 8, 2017
Report 1220948-2017-00069 · MDR key 7100933
Device
Product problems
- Failure to Auto Stop
- Failure to Auto Stop
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL IN TRANSIT. A FINAL REPORT WILL BE PROVIDED ONCE WE RECEIVE AND EVALUATE THE COMPLAINT DEVICE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT. PHYSICIAN WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY.
Description of Event or Problem
RESECTOR KEEPS SPINNING EVEN AFTER RELEASING THE BUTTON.
Additional Manufacturer Narrative
THIS IS A FOLLOW-UP REPORT IN REFERENCE TO INITIAL MANUFACTURER REPORT NUMBER 1220948-2017-00069 THAT WAS SUBMITTED ON 12/8/2017. OUR INVESTIGATION ON THE COMPLAINT DEVICE DID NOT FIND ANY ISSUE WITH THE DEVICE. THE HOUSING AND THE POWER CORD WERE INSPECTED AND WERE FOUND TO BE ACCEPTABLE. DEVICE WAS FOUND TO BE OPERATING ON ALL SETTINGS AND FUNCTIONS. WE COULD NOT REPLICATE THE DEFECT AS DESCRIBED IN THE COMPLAINT DESCRIPTION. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT SINCE THE DEVICE WAS FOUND TO BE OPERATIONAL.
Description of Event or Problem
RESECTOR KEEPS SPINNING EVEN AFTER RELEASING THE BUTTON.