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

Model Number 554-2003-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

The specific model of microtip device used in the procedure was not reported.The tx2 microtip was entered on this report because it is used more often than the other models of microtips.If any additional information is obtained, a follow-up report will be filed.The date of the procedure was not reported.The date of company notification was entered for the date of event.

Event Description

A patient reported nerve pain and loss of function in her arm following a shoulder procedure with a tenex health device.She was concerned that the technique used by the physician and the duration of the procedure may have been atypical.

• 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: 15859072
• MDR Text Key: 304275506
• Report Number: 1000135560-2022-00031
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006154
• UDI-Public: (01)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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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: 10/26/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Sex: Female