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

Model Number	554-3003-001
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.Due to the state in which the device was received, functional testing could not be performed.Disassembly of the device showed burn marks 1/4 of an inch from the needle tip and a slight bend in the needle.It appears that mechanical stress on the device lead to friction and local heat during operation.
Event or Problem Description
During a procedure with the tenex system, the physician noticed a burning odor coming from inside the treatment area.The device was removed and showed burned marks on the tip of the device, but no skin burn was observed on the patient.

• Brand Name: TXB TISSUE REMOVAL SYSTEM - 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 8123
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630-8123 ; 9492388220
• MDR Report Key: 23033730
• Report Number: 1000135560-2025-00032
• Device Sequence Number: 18520372
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093(10)1472506(17)270527
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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
• Device Lot Number: 1472506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: Unknown