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

Model Number 554-2003-001

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Rupture (2208)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

The patient presented to the treating physician with a refractory problem with both achilles tendons that had failed to respond to conservative treatment.The lesions in the tendons were apparently very large.The patient was an ultrarunner.Treatment with the tenex health tx system was apparently conducted in an attempt to avoid open surgery.Open surgery, however, did end up being necessary for the left achilles tendon.This tendon apparently did not respond positively to the treatment with the tenex health tx system.It is unclear what specific technique(s) was utilized in the treatment.

Event Description

A patient reported a tear in the achilles tendon 8 weeks after a procedure with the tenex health tx system.The patient experienced the rupture after weighting the toes, flexing the foot and stressing the achilles tendon.The tendinosis was apparently a refractory condition that involved a very large lesion.The patient also reported damage to the sural nerve experienced during the procedure.The patient has since had an open surgery to repair the achilles tendon tear and is apparently healing.It is unclear if the treatment with the tenex health tx system contributed to the tear, or if the tear was more directly a result of the severity of the existing condition.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TX2 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: 9753842
• MDR Text Key: 189289793
• Report Number: 1000135560-2020-00009
• Device Sequence Number: 1
• Product Code: LFL
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/26/2020
• 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: 40 YR