MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. ULTHERA SYSTEM

Model Number	UC-1
Medical Device Problem Codes	Failure to Power Up (1476); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While troubleshooting issues with an ulthera system for an unrelated event on (b)(6) 2022, a customer alleged that sparks emitted from the back of their control unit.The user stated the sparks originated from the area of the connection of the power cord to the back of the machine, and occurred when the system was turned on.Following this event, the system would no longer turn on.The user stated the plug appeared intact with no sign of fraying, and the power cord was fully seated into the control unit.The user was directed to cease use of this system immediately.The practice confirmed no injury to user or any patients were related to this event.No additional information is available at this time.
Additional Manufacturer Narrative
The ulthera control unit and associated power cord were returned to merz on (b)(6) 2021.This control unit has been submitted for complete diagnostic evaluation and testing.No further information is available at this time.When the service investigation has been completed, a supplemental will be submitted.
Additional Manufacturer Narrative
The ulthera control unit and associated power cord were returned to merz on 08-dec-2022.A preliminary investigation was performed by a merz biomedical electrical engineer.During this evaluation, no signs of damage, electrical damage, or other deviations were observed with the control unit nor the power cord.The unit was evaluated and was found to be in normal working condition.This control unit and power cord were then submitted for complete diagnostic evaluation and testing.During evaluation, the device was powered on/off several times and tested by firing 200 lines with multiple transducers.No sparking, evidence of sparking, or other issues were identified.The device met all functional requirements and passed all testing performed.Based on these findings, the reported issue of sparking occurring at the connection of the ulthera control unit and power cord was not confirmed.An evaluation of the original device history record (dhr) found no rework or non-conformances were associated with the manufacture of this device.All tests conducted passed on the first attempt.One deviation was noted; however, this deviation was not related and would not have contributed to the reported issue.An evaluation of the service history record (shr) for this control unit revealed this device has been returned for service on two previous occasions prior to this event.The reported issues and subsequent service activities previously performed would not have contributed to this event.A review of the most recent ulthera product complaint trending analysis revealed this issue has not occurred at high enough frequency to generate a trend and will continue to be monitored.Although the sparking issue was not replicated during evaluation and this control unit completed servicing and repair, in an abundance of caution this device will be scrapped to ensure no safety risk.No additional information is available at this time.If additional information is received, a supplemental medwatch will be submitted.

• Brand Name: ULTHERA SYSTEM
• Common Device Name: ULTHERA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer (Section G): MERZ-WISCONSIN; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer Contact: ashley ransom ; 13900 w. grandview parkway; sturtevant, WI 53177 ; 2628351911
• MDR Report Key: 16025772
• Report Number: 3006560326-2022-00010
• Device Sequence Number: 14821951
• Product Code: OHV
• UDI-Device Identifier: 00840763100179
• UDI-Public: 00840763100179
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UC-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown