MAUDE Adverse Event Report: TENEX HEALTH TX1 TISSUE REMOVAL SYSTEM - MICROTIP; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-1003-001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

The device was received by the manufacturer with the nose cone severely damaged.It could not be determined if all of the material was present due to the distortion and melting of the sheath.The microtip was side-loaded during operation and the friction resulted in heat build up and subsequent damage to the outer nose cone.It is highly probable, based upon the fracturing of the device, that the microtip made contact with hard tissue.The damage to the device is attributed to improper technique by the user.The device was not functionally tested as the handpiece had been separated from the tubing and cartridge.Only the handpiece was received.Visual evaluation was conducted on the returned portion of the device.

Event Description

Per the reporter, the procedure was completed without complications.When the doctor pulled the microtip out of the patient, the sales representative noticed the nose cone looked as if the sheath was melted.The doctor was not near bone or hard tissue.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): TENEX HEALTH; 26902 vista terrace; lake forest CA 92630
• Manufacturer (Section G): TENEX HEALTH; 26902 vista terrace; lake forest CA 92630
• Manufacturer Contact: alison baxter ; 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 5089126
• MDR Text Key: 26229540
• Report Number: 3009750704-2015-00592
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 09/18/2015

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
• Device Operator: Physician
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 35814-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2014
• 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: 60 YR
• Patient Weight: 111