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

Model Number	554-3003-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cellulitis (1768); Pain (1994); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: it is unclear whether any of the reported adverse events that occurred were directly attributable to the use of the tx system.Specifically, amputation is a common occurrence associated with dfu cases, particularly with late-term progression of dfu wounds.Progression to amputation may be associated with the pre-existing disease state.Cellulitis, chronic pain, and blister formation may also be associated with the patients' pre-existing disease state.
Event or Problem Description
In the article "rationale and technique for subulcer ultrasonic treatment of hard-to-heal diabetic foot ulcers" by freed et al,, 20 complications were reported in patients who underwent a diabetic foot ulcer (dfu) procedure with the tx system.Excerpt from the article, "complications occurred in 20 patients (infection: 8; cellulitis: 5; chronic pain: 3; amputation: 2; blister formation: 2)".Of the 20 complications reported, mdrs were previously submitted for 9 adverse events (8 infection and 1 cellulitis) and are listed in section h10.This freed article includes review of the same data set that was reviewed and presented previously (but without discussion of all aes).The remaining 11 cases were not previously known to tenex health and are summarized in this form 3500a: 4 cellulitis, 3 chronic pain, 2 amputations, and 2 blister formations.

• 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: 24273618
• Report Number: 1000135560-2026-00002
• Device Sequence Number: 10658799
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 11
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 01/06/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability; Other
• Patient Sex: Unknown