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

Model Number	554-0000-000
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Wheal(s) (2241)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that the microtip probe continued to spray saline irrigation fluid after the system foot pedal was no longer depressed.A welt developed over the operative site in the patient, that the physician was unable to aspirate.
Additional Manufacturer Narrative
The reported device on this form was corrected from a microtip to a tx console.The console was returned and evaluated.Corrosion was evident on a reflux valve in the recess where the microtip catridge connects to the console.The valve was stuck and allowed flow of fluid through the microtip tubing without depressing the foot pedal to activate cutting power.The valve degradation was attributed to fluid ingress/contamination into that part of the console.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - TX CONSOLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11137157
• Report Number: 1000135560-2021-00001
• Device Sequence Number: 17154510
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: 00857156006215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 554-0000-000
• Device Catalogue Number: 554-0000-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other