ULTHERA SYSTEM
Report
- Report Number
- 3006560326-2023-00002
- Event Type
- Malfunction
- Date Received
- June 2, 2023
- Date of Event
- January 21, 2023
- Report Date
- January 21, 2023
- Manufacturer
- MERZ NORTH AMERICA, INC.
- Product Code
- OHV
- UDI-DI
- 00840763100919
- PMA / PMN Number
- K180623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PRACTICE RETURNED ULTHERA HANDPIECE (SERIAL NUMBER: (B)(6)) AND ASSOCIATED CONTROL UNIT (SERIAL NUMBER: (B)(6)) FOR EVALUATION. TESTING PERFORMED ON THE HANDPIECE DID NOT REPLICATE OR CONFIRM THE REPORTED ISSUES OF CODE M, AUDIBLE NOISE ISSUE, HANDPIECE BUTTON FUNCTION, OR PATIENT OR USER SHOCK. ALL FUNCTIONAL TESTING PASSED, AND NO COMPONENTS RELATED TO THE REPORTED ISSUES WERE REPLACED. THE HANDPIECE AND ASSOCIATED CONTROL UNIT WERE ALSO SUBMITTED TO MERZ ULTHERA SENIOR BIOMEDICAL ENGINEER FOR ADDITIONAL EVALUATION TO FURTHER INVESTIGATE THE REPORTED ISSUE OF PATIENT OR USER SHOCK. THE CONSOLE AND HANDPIECE WERE POWERED UP AND SEVERAL THERAPY LINES WERE APPLIED WITH A TRANSDUCER. THE DEVICES PERFORMED AS EXPECTED AND THERE WERE NO MALFUNCTIONS OR DEVICE DISCREPANCIES. DUE TO THE REPORTED ISSUE OF USER SHOCK, AN ANALYSIS OF ELECTRICAL ENERGY SOURCES WAS PERFORMED. HUMANS CAN EXPERIENCE ELECTRICAL SHOCK SENSATIONS WHEN HIGH VOLTAGE ARCS THROUGH THE AIR FROM A CIRCUIT TO THE SKIN. HUMANS CAN ALSO EXPERIENCE ELECTRICAL SHOCK SENSATIONS WHEN THE BODY BECOMES PART OF THE CURRENT PATH (TYPICALLY TO GROUND). APPROXIMATELY 75,000 VOLTS PER INCH ARE REQUIRED FOR ELECTRICITY TO ARC IN CLEAR AIR. HUMANS BEGIN TO FEEL STATIC DISCHARGE AT OR AROUND 2,000 VOLTS. AS SUCH, ANALYSIS SHOULD CONSIDER HIGH VOLTAGE AND ISOLATION FROM HIGH VOLTAGE. THE HIGHEST VOLTAGE PRESENT AT THE HANDPIECE OCCURS DURING IMAGING AND THERAPY DELIVERY. THE DRIVING SIGNALS CAN BE MEASURED AT THE CONSOLE FRONT PANEL CONNECTOR. THIS IS THE STAGE OF THE SIGNAL CHAIN WITH THE HIGHEST LEVEL OF THESE SIGNALS. AS THE SIGNALS ARE DELIVERED INTO HANDPIECE COAX CABLES, CIRCUIT BOARDS, AND EVENTUALLY ULTRASOUND TRANSDUCERS, THE SIGNALS ARE CONTINUALLY ATTENUATED. THE HIGHEST IMAGING SIGNAL IS A TYPICAL 40.6VP-P AND THE HIGHEST TYPICAL THERAPY SIGNAL IS 14.2VP-P. THE HANDPIECE PROVIDES AN INTERNAL AIR GAP AND HAS A NON-CONDUCTIVE PLASTIC COVER THAT ISOLATES THE USER FROM INTERNAL ELECTRICAL SIGNALS; NO DAMAGE WAS NOTED DURING DEVICE EVALUATION. ADDITIONAL INVESTIGATION INTO PATIENT OR USER SHOCK DETERMINED THE ULTHERA SYSTEM PROVIDES THE PATIENT AND CLINICIAN SAFETY FROM MAINS ENERGY HAZARDS, ULTRASOUND DRIVE SIGNAL HAZARDS, MOTION HAZARDS, AND UNINTENDED ULTRASOUND THERAPY HAZARDS BY DESIGN AND IS CONFIRMED BY MANUFACTURING TEST. A CODE M FAULT CONDITION WAS OBSERVED BY THE CLINICIAN. CODE M IS A SYSTEM FAULT ENCOUNTERED WHEN THE MOTION IS HALTED. THE MOTION IS MONITORED FOR CORRECT POSITION AND FOR A NOMINAL DRIVE POWER IN ORDER TO HALT MOTION BEFORE HARM TO THE USER OR DAMAGE IS DONE TO THE DEVICE. THE TYPICAL CODE M FAULT WILL PRESENT WITH A RATCHETING SOUND AS THE INTERNAL STEPPER MOTOR ATTEMPTS TO CONTINUE MOTION. AN ABRUPT MECHANICAL VIBRATION MAY ALSO BE FELT BY THE USER. THE COMBINATION OF SOUND AND FEEL MAY BE PERCEIVED AS AN ELECTRICAL SHOCK. NO ISSUES WERE IDENTIFIED WITH THE CONTROL UNIT DURING EVALUATION. BY DESIGN, THE HANDPIECE DOES NOT PRESENT HIGH VOLTAGE TO THE USER AND ISOLATES THE USER FROM ELECTRICAL SIGNALS. THE HANDPIECE DOES NOT HAVE THE POTENTIAL TO SERIOUSLY SHOCK A PATIENT OR CLINICIAN. THE HANDPIECE OPERATED NORMALLY, AND THE ALLEGATION OF SHOCK WAS NOT CONFIRMED. THE USER EXPERIENCE WAS LIKELY DUE TO THE EFFECTS OF THE MOTION HALTING. A REVIEW OF THE SUPPORT LOG CONFIRMED CODE M OCCURRED WHILE THE HANDPIECE AND CONTROL UNIT ASSOCIATED WITH THIS EVENT WERE IN USE. BASED ON THE INFORMATION AVAILABLE, THE REPORTED ISSUE OF CODE M WAS CONFIRMED DURING REVIEW OF THE SUPPORT LOG. HOWEVER, THIS ISSUE WAS NOT REPLICATED DURING EVALUATION AND THE ROOT CAUSE OF THIS ISSUE IS UNKNOWN. THE REPORTED ISSUES OF PATIENT OR USER SHOCK, HANDPIECE BUTTON FUNCTION, AND AUDIBLE NOISE ISSUE WERE NOT REPLICATED/CONFIRMED DURING EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HANDPIECE 19D081215 FOUND NO NON-CONFORMANCES, REWORK, OR DEVIATIONS ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE. ALL REQUIRED TESTS PASSED PRIOR TO DISTRIBUTION. A REVIEW OF THE SERVICE HISTORY RECORD (SHR) FOR HANDPIECE 19D081215 REVEALED THIS DEVICE WAS SERVICED ONCE IN 2020. THIS HANDPIECE PASSED ALL TESTING PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR CONTROL UNIT 19B072605 FOUND NO NON-CONFORMANCES, REWORK, OR DEVIATIONS ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE. ALL REQUIRED TESTS PASSED PRIOR TO DISTRIBUTION. A REVIEW OF THE SERVICE HISTORY RECORD (SHR) FOR CONTROL UNIT 19B072605 REVEALED THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED SINCE DISTRIBUTION. A REVIEW OF THE CURRENT ULTHERA PATIENT COMPLAINT TRENDING ANALYSIS REVEALED THE REPORTED ISSUE OF PATIENT OR USER SHOCK HAS NOT OCCURRED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. A REVIEW OF THE CURRENT ULTHERA PRODUCT COMPLAINT TRENDING ANALYSIS REVEALED THE REPORTED ISSUES OF CODE M AND AUDIBLE NOISE ARE BEING FURTHER INVESTIGATED WITHIN A CAPA. A REVIEW OF THE CURRENT ULTHERA PRODUCT COMPLAINT TRENDING ANALYSIS REVEALED THE REPORTED ISSUE OF HANDPIECE BUTTON FUNCTION HAS NOT OCCURRED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. THE PATIENT INVESTIGATION FOUND THAT THERE ARE NOT ENOUGH DETAILS TO CONFIRM WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE REPORT WAS INITIALLY DEEMED SERIOUS FOLLOWING DISCUSSION WITH THE MERZ PRODUCT SAFETY TEAM AS PATIENT OR USER SHOCK MAY HAVE HAD THE POTENTIAL TO LEAD TO A SERIOUS DETERIORATION OF THE PATIENT´S OR USER´S STATE OF HEALTH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THE ULTHERA HANDPIECE ASSOCIATED WITH THIS EVENT WAS RETURNED TO MERZ GERMANY FOR SERVICING ON (B)(6) 2023. THIS DEVICE HAS BEEN REQUESTED TO BE SENT TO MERZ UNITED STATES AND WILL BE SUBMITTED FOR COMPLETE DIAGNOSTIC EVALUATION AND TESTING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WHEN THE SERVICE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
ON 21-JAN-2023, A BELGIUM MERZ/ULTHERA AFFILIATE REPORTED VIA EMAIL A HANDPIECE WITH BUTTON FUNCTION ISSUES. ON 23-JAN-2023, THE AFFILIATE PROVIDED AN UPDATED REPORT FROM THE CUSTOMER STATING THE HANDPIECE WAS ASSOCIATED WITH CODE M AND WAS MAKING STRANGE NOISES. DURING TROUBLESHOOTING, A FULL POWER CYCLE WAS PERFORMED TWO TIMES. DURING THE POWER CYCLE, THE REPORTER STATED "THE NURSE FELT THE SORT OF ELECTRICAL SHOCK IN THE HANDPIECE. SHE WAS NOT TREATING ANYONE AS SHE WAS TESTING HER TRANSDUCERS. SHE DESCRIBED IT AS A LIGHT SHOCK." THE USER REPORTED NO LINGERING SYMPTOMS OR ISSUES OCCURRED. THE REPORTER STATED THERE IS A POSSIBILITY THE SHOCK THE NURSE ENCOUNTERED WAS A STATIC SHOCK; HOWEVER, THIS CANNOT BE CONFIRMED WITH CERTAINTY. NO PATIENT IMPACT WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WAS INITIALLY SUBMITTED UNDER AN INCORRECT MANUFACTURER FEI NUMBER: 3006560326-2023-00013. THIS REPORT IS BEINGRESUBMITTED UNDER THE CORRECT NUMBER: 3006560326-2023-00002.
ON (B)(6) 2023, A BELGIUM MERZ/ULTHERA AFFILIATE REPORTED VIA EMAIL A HANDPIECE WITH BUTTON FUNCTION ISSUES. ON (B)(6) 2023, THE AFFILIATE PROVIDED AN UPDATED REPORT FROM THE CUSTOMER STATING THE HANDPIECE WAS ASSOCIATED WITH CODE M AND WAS MAKING STRANGE NOISES. DURING TROUBLESHOOTING, A FULL POWER CYCLE WAS PERFORMED TWO TIMES. DURING THE POWER CYCLE, THE REPORTER STATED "THE NURSE FELT THE SORT OF ELECTRICAL SHOCK IN THE HANDPIECE. SHE WAS NOT TREATING ANYONE AS SHE WAS TESTING HER TRANSDUCERS. SHE DESCRIBED IT AS A LIGHT SHOCK." THE REPORTER STATED THERE IS A POSSIBILITY THE SHOCK THE NURSE ENCOUNTERED WAS A STATIC SHOCK; HOWEVER, THIS CANNOT BE CONFIRMED WITH CERTAINTY. NO PATIENT IMPACT WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WAS INITIALLY SUBMITTED UNDER AN INCORRECT MANUFACTURER FEI NUMBER: (B)(4). THIS REPORT IS BEING RESUBMITTED UNDER THE CORRECT NUMBER:
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1648491 | ULTHERA SYSTEM | ULTHERA SYSTEM | OHV | MERZ NORTH AMERICA, INC. | UH-2 | H19H00120 | 00840763100919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |