MAUDE Adverse Event Report: TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-1003-001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Contracture (4528)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported loss of some arm function (pronation) a year after a procedure with the tenex health tx system on his elbow.The treating physician did not note any issues during the procedure or at post-operative follow-up.It is unclear if the present condition is related to the prior treatment with the tx system.
Additional Manufacturer Narrative
Follow-up report #01.Additional information was obtained on patient's other relevant history and further medical consultations.Another physician reviewed multiple sources of test data from the patient's affected arm and could not determine a source of the reported symptoms (or connection to treatment with the tenex health device).
Additional Manufacturer Narrative
Additional information was obtained on patient's other relevant history and further medical consultations.Patient reported a separate injury to the affected arm after treatment with the tenex device.Follow-up imaging revealed a nerve "impingement" related to this injury.It was concluded that the "procedure" with the tenex device was not related to the reported adverse event.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11904839
• Report Number: 1000135560-2021-00040
• Device Sequence Number: 4247309
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: (01)00857156006215
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123640
• 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,Followup
• Report Date (Section B): 10/22/2021

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: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 04/30/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/29/2021; 10/22/2021
• 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