MAUDE Adverse Event Report: TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 554-1003-002

Device Problem Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Although the lot number for the affected device was not reported, possible lot numbers for deliveries to the distributor were identified and production records were reviewed.No anomalies or issues were identified in production.Pictures of the removed needle fragment were provided by the reporter.It was confirmed that the microtip needle had separated from the rest of the handpiece.The fracture site did not immediately indicate a specific cause for the failure.

Event Description

During a procedure with the tenex system, a portion of the microtip needle separated from the rest of the hand piece.The section of needle was temporarily retained in the patient.When the patient returned to the hospital reporting pain in the area, the fragment was located and removed.There were no additional complications reported.

• Brand Name: TX1 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: 18764221
• MDR Text Key: 336054948
• Report Number: 1000135560-2024-00009
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-1003-002
• Device Catalogue Number: 554-1003-002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 36 YR
• Patient Sex: Male