TRIVEX SYSTEM RESECTOR HANDPIECE
Received Jan 3, 2018
Report 1220948-2017-00074 · MDR key 7162346
Device
Product problems
- Failure to Auto Stop
- Failure to Auto Stop
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 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 HAS TO POWER OFF THE CONTROL UNIT TO PREVENT THE UNIT FROM SPINNING.
Description of Event or Problem
RESECTOR HANDPIECE DID NOT STOP SPINNING AFTER RELEASING THE BUTTON.
Additional Manufacturer Narrative
THIS IS A FOLLOW-UP REPORT IN REFERENCE TO MANUFACTURER REPORT NUMBER 1220948-2017-00074 THAT WAS SUBMITTED ON 01/03/2018. WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE ON 01/31/2018 . THE BEZEL WAS NOT SEATED PROPERLY ON THE HOUSING. IT WAS NOT STRAIGHT AND DID NOT ALIGN WELL, AS IF IT HAD BEEN TAMPERED. THE ELECTRICAL TESTING PROVIDED EXPECTED RESULTS INDICATING THE REED SWITCH BOARD FUNCTIONED CORRECTLY. THE MOTOR HAD TO BE FREED USING A SCREW DRIVER. ONCE FREED, THE MOTOR ROTATED NORMALLY. THE CORE OF THE MOTOR SHOWED SIGNS OF CORROSION AND RUST LIKELY DUE TO WATER INGRESS. TWO END BELL PINS WERE ALSO MISSING FROM THE ASSEMBLY. THIS DEVICE WAS SHIPPED TO THE DISTRIBUTOR FOR SALE ON 04/27/2016. THE ROOT CAUSE OF FAILURE WAS DETERMINED TO BE BEARING CORROSION AND SEIZURE DUE TO WATER INGRESS THROUGH A FAILED SEAL. THE SEAL LIKELY FAILED DUE TO EXCESSIVE WEAR FROM REPEATED CLEANING, USE AND STERILIZATION.
Description of Event or Problem
RESECTOR HANDPIECE DID NOT STOP SPINNING AFTER RELEASING THE BUTTON.