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

Model Number 554-3003-001

Device Problems Overheating of Device (1437); Use of Device Problem (1670)

Patient Problems Skin Irritation (2076); Post Operative Wound Infection (2446)

Event Date 07/09/2020

Event Type  Injury  

Event Description

A patient developed a wound breakdown, with delayed healing, three weeks after a procedure with the tx system.It appeared to be a post-procedure infection.The exact cause of the breakdown is unclear.The patient's healing ability and circulation in the leg may have been compromised.No patient injury or complications were evident immediately after the procedure or at the one-week follow-up.Some reddening of the skin was seen at two weeks.But, overheating of the microtip during the procedure may have potentially contributed to the condition.However, the extent of the lesion was far beyond the possible zone of local thermal damage.Probe placement and use subcutaneously, with tissue embedding and blockage of the irrigation, could have also potentially contributed to the condition.

• Brand Name: TXB TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest, ca
• Manufacturer (Section G): TENEX HEALTH, INC.; 26902 vista terrace; lake forest, ca
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, ca ; 2388220
• MDR Report Key: 10399800
• MDR Text Key: 202695206
• Report Number: 1000135560-2018-00037
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: 00857156006093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Device Lot Number: 04220-02-202201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other