MAUDE Adverse Event Report: TENEX HEALTH, INC. TX SYSTEM - TXB MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-3003-001
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Pain (1994); Ambulation or Postural Difficulties (2544); Superficial (First Degree) Burn (2685); Swelling/ Edema (4577)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note that the patient's medwatch report included a statement that "infection is noted as possible adverse reaction to procedure, but thermal burn was not mentioned as possible reaction to this procedure." burns are, in fact, included in the list of adverse effects in the ifu provided with every device.
Event or Problem Description
A patient reported through the fda medwatch program that they had experienced a thermal burn and an infection following a procedure with a tenex health tx system device.Symptoms manifested five days postoperatively and included pain, swelling, redness and an inability to bear weight on the operative foot.

• Brand Name: TX SYSTEM - TXB MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer (Section G): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630 ; 9492388220
• MDR Report Key: 17881609
• Report Number: 1000135560-2023-00046
• Device Sequence Number: 7770139
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female