SONABLATE

Additional Manufacturer Narrative

THE MALFUNCTIONING RF AMPLIFIER WAS SENT TO THE SUPPLIER FOR ADDITIONAL EVALUATION, AND THE SUPPLIER CONFIRMED THE SAME ISSUE IDENTIFIED BY THE MANUFACTURER. THE SUPPLIER INDICATED, "THE PROBLEM THAT CAUSED THE WRONG READINGS WAS A BROKEN 0805 RESISTOR IN THE REFLECTOMETER CIRCUIT. THIS CAUSED IMPROPER READINGS TO BE SENT BACK TO THE CONTROL CIRCUIT, THUS AFFECTING THE OUTPUT." THIS RESISTOR IS A TINY SURFACE-MOUNT, PASSIVE COMPONENT OF A PRINTED CIRCUIT ASSEMBLY. SUCH PARTS ARE GENERALLY LONG LASTING AND RELIABLE. FOR EXAMPLE, THE SPECIFIED FAILURE RATE BY THE MANUFACTURER OF THE RESISTOR IS LESS THAN OR EQUAL TO 0.1 X 10-9/H. THE EXACT CAUSE FOR THE BROKEN RESISTOR COULD NOT BE IDENTIFIED; HOWEVER, THIS WAS DETERMINED TO BE A RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. AT THIS TIME, THERE IS STILL NO REPORT OF INJURY OR OTHER ADVERSE EFFECT TO THE PATIENT.

Description of Event or Problem

DURING PATIENT TREATMENT, PHYSICIAN AND CASE SUPPORT SPECIALIST ENCOUNTERED AN UNEXPECTED AMOUNT OF NEAR FIELD CHANGES. THE TREATMENT WAS IMMEDIATELY PAUSED AND CONFIRMED NO NITROUS OXIDE WAS BEING USED AS ANESTHETIC, WHICH CAN INCREASE THE GENERATION OF ECHOGENIC CHANGES. AFTER A FEW MINUTES OF PAUSING, THE TREATEMENT WAS CONTINUED. THE NEAR FIELD CHANGES CONTINUED. TOTAL ACCOUSTIC POWER (TAP) LEVELS WERE LOWERED AND THE PHYSICIAN CONTINUED TO PAUSE AS INSTRUCTED BY THE USER MANUAL. TO PROCEED, THE PHYSICIAN UPDATED THE VOLUME STACK AND CONTINUED. LESS NEAR FIELD CHANGES WERE OBSERVED BUT PERSISTED IN SUBSEQUENT TREATMENT ZONES. TOTAL TIME PAUSED DURING TREATMENT TO RESOLVE NEAR FIELD CHANGES WAS APPROXIMATELY 45 MINUTES. PATIENT TREATMENT WAS COMPLETED WITH NO REPORT OF AN ADVERSE EVENT OR INJURY. SUBSEQUENT SERVICE OF THE DEVICE WAS PERFORMED ONSITE BY THE MANUFACTURER'S SERVICE ENGINEER, AND THE ISSUE WAS TRACED TO THE MALFUNCTION OF THE RF AMPLIFIER. THE RF AMPLIFIER WAS REPLACED, AND NORMAL POWER LEVELS WERE OBSERVED. A FULL CALIBRATION AND VERIFICATION OF THE SYSTEM WAS PERFORMED WITH NO FURTHER ISSUES. THE RF AMPLIFIER WAS SHIPPED TO THE MANUFACTURING FACILITY FOR INSPECTION, TESTING, AND CONFIRMATION OF THE ISSUE AS DESCRIBED. THE TESTING SHOWED THE OUTPUT GAIN WAS HIGHER THAN EXPECTED. THIS INFORMATION WAS SHARED WITH THE SUPPLIER, AN RMA WAS RECEIVED FROM THE SUPPLIER, AND THE RF AMP WAS SHIPPED TO THE SUPPLIER FOR EVALUATION.

Description of Event or Problem

DURING PATIENT TREATMENT, PHYSICIAN AND CASE SUPPORT SPECIALIST ENCOUNTERED AN UNEXPECTED AMOUNT OF NEAR FIELD CHANGES. THE TREATMENT WAS IMMEDIATELY PAUSED AND CONFIRMED NO NITROUS OXIDE WAS BEING USED AS ANESTHETIC, WHICH CAN INCREASE THE GENERATION OF ECHOGENIC CHANGES. AFTER A FEW MINUTES OF PAUSING, THE TREATMENT WAS CONTINUED. THE NEAR FIELD CHANGES CONTINUED. TOTAL ACOUSTIC POWER (TAP) LEVELS WERE LOWERED AND THE PHYSICIAN CONTINUED TO PAUSE AS INSTRUCTED BY THE USER MANUAL. TO PROCEED, THE PHYSICIAN UPDATED THE VOLUME STACK AND CONTINUED. LESS NEAR FIELD CHANGES WERE OBSERVED BUT PERSISTED IN SUBSEQUENT TREATMENT ZONES. TOTAL TIME PAUSED DURING TREATMENT TO RESOLVE NEAR FIELD CHANGES WAS APPROXIMATELY 45 MINUTES. PATIENT TREATMENT WAS COMPLETED WITH NO REPORT OF AN ADVERSE EVENT OR INJURY. SUBSEQUENT SERVICE OF THE DEVICE WAS PERFORMED ONSITE BY THE MANUFACTURER'S SERVICE ENGINEER, AND THE ISSUE WAS TRACED TO THE MALFUNCTION OF THE RF AMPLIFIER. THE RF AMPLIFIER WAS REPLACED, AND NORMAL POWER LEVELS WERE OBSERVED. A FULL CALIBRATION AND VERIFICATION OF THE SYSTEM WAS PERFORMED WITH NO FURTHER ISSUES. THE RF AMPLIFIER WAS SHIPPED TO THE MANUFACTURING FACILITY FOR INSPECTION, TESTING, AND CONFIRMATION OF THE ISSUE AS DESCRIBED. THE TESTING SHOWED THE OUTPUT GAIN WAS HIGHER THAN EXPECTED. THIS INFORMATION WAS SHARED WITH THE SUPPLIER, AN RMA WAS RECEIVED FROM THE SUPPLIER, AND THE RF AMP WAS SHIPPED TO THE SUPPLIER FOR EVALUATION.

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION OF THIS EVENT IS STILL ONGOING. THE MALFUNCTIONING PART HAS BEEN SENT BACK TO THE SUPPLIER FOR ADDITIONAL EVALUATION AND HAS NOT YET BEEN RETURNED. ADDITIONALLY, THE MANUFACTURER HAS OBTAINED CASE IMAGES FROM THIS TREATMENT AS WELL AS FROM ALL CASES THAT OCCURRED SINCE THE DEVICE WAS LAST SERVICED TO REVIEW FOR SIMILAR ISSUES OF NEAR FIELD CHANGES.