MAUDE Adverse Event Report: TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-1003-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
At the beginning of a procedure with the tenex system, a portion of the microtip needle separated from the rest of the hand piece and was retrieved.There were no patient complications.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11636619
• Report Number: 1000135560-2021-00023
• Device Sequence Number: 3495987
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: (01)00857156006215(10)2872001(17)221013
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 2872001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1