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

Model Number 554-3003-001

Device Problem Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 12/05/2019

Event Type  Injury  

Event Description

Following a procedure with the tenex system, blisters and skin burns were observed near the needle incision point.The patient was treated with antibiotics and healed normally.

Manufacturer Narrative

Follow-up report #01.It appears that the user used a smaller than specified bag of saline for irrigation, and a shorter than specified off-time for the duty cycle of use.These could have contributed to extra heat generation by the microtip.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 9577144
• MDR Text Key: 174556317
• Report Number: 1000135560-2020-00001
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K181367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1