THD REVOLUTION

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR TECHNICAL INVESTIGATION. BASED ON THE PRODUCT ANALYSIS RESULTS, THE ROOT CAUSE ANALYSIS OF THE FAILURE IS A RETRACTED CONTACT OF THE DOPPLER PROBE CONNECTOR PROBABLY OCCURRED AFTER INSTALLATION, CAUSED BY USE OF THE DEVICE OVER TIME. THE INVESTIGATION OF THE COMPLAINT WITH REFERENCE TO THE MANUFACTURING RECORDS FOUND THAT THE SUBJECT DEVICE PASSED THE FINAL TESTS PERFORMED BEFORE THE RELEASE FOR DISTRIBUTION AND NO ANOMALIES WERE FOUND (THE DOPPLER SIGNAL COULD BE REGULARLY HEARD), SO THE DEVICE WAS WORKING PROPERLY AT THE END OF THE PRODUCTION PROCESS. WE EMPHASIZE THAT THE DEVICE WAS MANUFACTURED IN 2017 AND THAT THE REPORTED PROBLEM OCCURRED AFTER ABOUT 40 HOURS OF OPERATION OF THE DEVICE, WHICH HAD NEVER BEFORE EXPERIENCED ANY PROBLEMS. COMPLAINTS TREND ANALYSIS DID NOT FOUND ANY SIMILAR EVENTS REPORTED ON THE SAME DEVICE ON OVER 700 DEVICES INSTALLED AND OVER 26.000 SURGICAL TREATMENT PERFORMED FROM 2017. WE THEREFORE CONSIDER THE EVENT A RARE AND ISOLATED PROBLEM COMPATIBLE WITH A MANUFACTURING DEFECT OF THE CONNECTOR NOT DETECTABLE AT THE TIME OF THE PRODUCTION CHECKS, BUT HIGHLIGHTED ONLY AFTER USE OF THE DEVICE OVER TIME. THE MONITORING ACTIVITY ON NEW DEVICES IS CARRIED OUT ROUTINELY. SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

NO DOPPLER SOUND CAN BE HEARD FROM THE THD REVOLUTION DURING THE OPERATION. THE STAFF THEN CHANGED THE THD SLIDE SET, BUT THEY COULD NOT HEAR ANY DOPPLER SIGNAL. THE OPERATION WAS COMPLETED WITHOUT PROBLEMS FOR THE PATIENT USING ANOTHER DEVICE.