OSCILLATING ULTRASONIC PROBE

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; HOWEVER, OUR SALES REPRESENTATIVE VIEWED THE DEVICE AND ALSO PROVIDED A PICTURE, WHICH SHOWS THREE PIECES WERE BROKEN OFF OF THE OSCILLATING PROBE TIP. THE HOSPITAL CONFIRMED THAT THE BROKEN PIECES WERE RETRIEVED AND THERE WAS NO HARM TO PATIENT. IN ADDITION, WE LEARNED FROM THE HOSPITAL THAT THE KIDNEY STONE WAS VERY HARD AND THAT AFTER THE SURGEON HAD BEEN WORKING ON IT FOR SOME TIME USING THIS PROBE, THE ULTRASONIC CALCUSON UNIT DISPLAYED A WARNING LIGHT; HE CONTINUED USING THE PROBE AND THE TIP EVENTUALLY BROKE. IT IS POSSIBLE THE WARNING LIGHT WAS THE TRANSDUCER FAULT INDICATOR - RESONANCE WARNING, WHICH CAN INDICATE EITHER A DAMAGED PROBE OR TRANSDUCER. A POSSIBLE ROOT CAUSE OF THIS TYPE OF BREAKAGE IS OVERHEATING AND/OR MECHANICAL OVERLOAD. BOTH ARE USER RELATED ISSUES AND ARE ADDRESSED IN OUR IFU.

Description of Event or Problem

ALLEGEDLY, DURING A PERCUTANEOUS NEPHROLITOMY PROCEDURE, THREE PIECES OF TIP OF THE ULTRASONIC PROBE BROKE OFF INTO THE PATIENT. THE BROKEN PIECES WERE RETRIEVED AND PROCEDURE WAS COMPLETED USING A DIFFERENT PROBE. HOSPITAL CONFIRMED THERE WAS NO INJURY TO PATIENT.