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

Model Number	554-3003-001
Medical Device Problem Codes	Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Codes	Skin Irritation (2076); Post Operative Wound Infection (2446)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest, ca
• MDR Report Key: 10399800
• Report Number: 1000135560-2018-00037
• Device Sequence Number: 11727344
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• 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