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

Model Number 554-3003-001

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 04/29/2022

Event Type  Injury  

Event 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.

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 Description

Duplicate report created by mistake.

• Brand Name: TXB TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: 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
• MDR Text Key: 292799481
• Report Number: 1000135560-2022-00012
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other