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

Model Number	554-1003-001
Medical Device Problem Codes	Fracture (1260); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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.There were no patient complications.
Additional Manufacturer Narrative
Follow-up report #02.Sections b4, b5, g6, h2 , h6 and h10 have been updated with new or corrected information.The device was returned and evaluated.It was confirmed that the plastic case nose of the handpiece had been partially melted and damaged.Due to the state in which the device was received, functional testing could not be performed.The damage did not immediately indicate a specific cause for the failure.Disassembly of the device did not reveal any further anomalies or defects.(note: it was initially reported that the microtip needle had broken, but it was later confirmed to be the plastic case only).
Event or Problem Description
A portion of the outer plastic case (case nose) on the tx microtip handpiece was damaged and partially melted during a procedure.(note: it was initially reported that the microtip needle had broken, but it was later confirmed to be the plastic case only.) there were no patient complications.
Additional Manufacturer Narrative
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: 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: 11845441
• Report Number: 1000135560-2021-00038
• Device Sequence Number: 4181126
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: (01)00857156006215(10)2612001(17)220917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

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: 09/17/2022
• Device Model Number: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 2612001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021; 04/19/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/10/2021; 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1