MAUDE Adverse Event Report: TENEX HEALTH, INC. TX2 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 554-2003-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

The specific model of tx system microtip was not specified in the article.It is suspected that the device was the tx2 microtip, which is specified in this report.The date of article publication was used for the incident date.The exact date of the treatment and event is not known.

Event Description

An adverse event following a procedure with the tx system was discovered in literature.A case of olecranon bursitis was reported following treatment with the tx system for triceps tendinopathy.It was reported, however, that the swelling resolved spontaneously within one week.The authors suspect that the fluid used to irrigate the pathologic tissue distended the bursal space.The article was: sussman wi, fanuele j and hackel jg.Ultrasonic percutaneous tenotomy for the treatment of recalcitrant triceps tendinopathy, journal of surgical techniques and procedures, 2019;3(2):1028.

• Brand Name: TX2 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer (Section G): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630 ; 9492388220
• MDR Report Key: 10782431
• MDR Text Key: 214534265
• Report Number: 1000135560-2020-00047
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006154
• UDI-Public: 00857156006154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 38 YR