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); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of a procedure with the tenex system, a portion of the microtip needle separated from the rest of the hand piece.It was also reported that the case nose plastic on the microtip appeared to be melted.The procedure was completed.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: 11021142
• Report Number: 1000135560-2020-00055
• Device Sequence Number: 3823309
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: 00857156006215
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 06/30/2020
• Device Model Number: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 19820-01-202206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR