MAUDE Adverse Event Report: TENEX HEALTH, INC. TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-3003-001
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
User ran out of saline irrigation during a procedure due to using a smaller than specified size saline bag (250cc instead of 1000cc).They reported the device was overheating as a result, and the patient developed a superficial skin burn at the treatment site.The burn started as a blister and was healing at 10 days post-op.It was reported that the wound was fully closed and the patient was pain-free after approximately 14 days.Patient may be under observation for 60 days.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11249071
• Report Number: 1000135560-2021-00012
• Device Sequence Number: 3563033
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: 00857156006093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/29/2021
• 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
• Patient Age: 49 YR