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

Model Number 554-2003-002

Device Problem Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

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

• 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: 18999346
• MDR Text Key: 339053539
• Report Number: 1000135560-2024-00014
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10857156006192
• UDI-Public: (01)10857156006192(10)2902205(17)241016
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K153299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-2003-002
• Device Catalogue Number: 554-2003-002
• Device Lot Number: 2902205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2023
• 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 Sex: Male
• Patient Ethnicity: Hispanic