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

Model Number	UC-1
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ulthera control unit and associated power cord were returned to merz on 23-apr-2021.A preliminary investigation was performed by a merz senior biomedical engineer on 29-apr-2021.During this investigation, no damage, evidence of charring, 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.In an attempt to replicate the issue, the power cord was partially inserted into the control unit and minor sparking was observed.This condition may be observed on most ac powered devices when there is a poor connection between a power supply and the device.This control unit has been sent 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.
Event or Problem Description
During a phone call with a practice for an unrelated event on (b)(6) 2021, merz ulthera received information an ulthera control unit was emitting sparks from the back of the unit where the power cord plugs into the back of the unit.This issue occurred when the user moved this device to another location within the practice and plugged it into the wall outlet.No additional information is available at this time.

• Brand Name: ULTHERA SYSTEM
• Common Device Name: ULTHERA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• MDR Report Key: 11787534
• Report Number: 3013840437-2021-00120
• Device Sequence Number: 11677400
• Product Code: OHV
• UDI-Device Identifier: 00840763100179
• UDI-Public: 00840763100179
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other