SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE
Received Oct 7, 2016 · Event occurred Sep 9, 2016
Report 0008043928-2016-00038 · MDR key 6010461
Device
Generic name
Instrument, Ultrasonic Surgical
Manufacturer
Stryker Instruments-inagiCatalog number
5450850000
Product problems
- Inability to Irrigate
- Inability to Irrigate
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY THE SALES REPRESENTATIVE AT THE USER FACILITY THE IRRIGATION PRIMING FUNCTION DID NOT WORK. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE IRRIGATION PRIMING FUNCTION DID NOT WORK. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.