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 Problems Hematoma (1884); Pain (1994); Swelling/ Edema (4577)

Event Date 12/08/2022

Event Type  Injury  

Event Description

During a procedure with the tenex system, a portion of the microtip needle separated from the rest of the handpiece and was retained in the treatment site.The patient experienced pain and swelling in the area.The piece was then removed from the site with another procedure.

• 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: 16118639
• MDR Text Key: 306878917
• Report Number: 1000135560-2023-00003
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006154
• UDI-Public: (01)00857156006154
• 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
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• 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