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

Model Number 554-2003-001

Device Problem Fracture (1260)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

During a procedure with the tenex system, the microtip needle separated from the rest of the hand piece.The procedure was completed with another microtip hand piece.There were no patient complications.

Manufacturer Narrative

Follow-up report #01.Sections b4, d9, g6, h2, h3, h6 and h10 have been updated with new information.The device was returned and evaluated.It was confirmed that the microtip needle had separated from the rest of the handpiece.Due to the state in which the device was received, functional testing could not be performed.The fracture site did not immediately indicate a specific cause for the failure.Disassembly of the device did not reveal any further anomalies or defects.

• Brand Name: TX2 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 ; 9492388220
• MDR Report Key: 17760963
• MDR Text Key: 324123445
• Report Number: 1000135560-2023-00036
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006154
• UDI-Public: (01)00857156006154(10)0552302(17)250223
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 0552302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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