MAUDE Adverse Event Report: TENEX HEALTH, INC. TX SYSTEM - TX2 MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 554-2003-001

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.It was confirmed that part of the microtip needle had separated from the rest of the handpiece.The fracture site did not immediately indicate a specific cause for the failure.Testing and disassembly of the device did not reveal any further anomalies or defects.

Event Description

During a procedure with the tenex system, a portion of the microtip needle separated from the rest of the handpiece and was retrieved from the patient.Another handpiece was used to complete the procedure.There were no patient complications.

• Brand Name: TX SYSTEM - TX2 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 ; 9492388220
• MDR Report Key: 17672548
• MDR Text Key: 322533662
• Report Number: 1000135560-2023-00034
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006144
• UDI-Public: (01)00857156006144(10)1522303(17)250531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Device Lot Number: 1522303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White