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

Model Number	554-3003-001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician had two patients from two different procedures performed on the same day, using the tenex health tx system, develop infections at the treatment sites.The procedures were performed on the achilles tendon.(different disposable tx handpieces were used on each patient).Patients were treated in the hospital for the infections.The physician did not report any issues with the device or patients during the procedures.The infections developed some time after the procedures.It is unclear if the infections were directly related to use of the tx system.
Additional Manufacturer Narrative
Follow-up report #01.There was no new incident to report here.The mdr was a duplicate created by mistake.The 2 incidents initially reported here have already been reported in 1000135560-2021-00062 and 1000135560-2021-00063.
Event or Problem Description
Duplicate report created by mistake.

• 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
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630 ; 9492380822
• MDR Report Key: 14519574
• Report Number: 1000135560-2022-00012
• Device Sequence Number: 5488086
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/20/2022
• 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: Unknown