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

Model Number 554-2003-001

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.It was confirmed that the microtip needle had wear on its outer surface near the adjacent, distal end of the needle sheath.The tip of the needle that contacts tissue was also bent over, consistent with forceful use on hard tissue, such as bone, which is outside the indications for use.The user also did report using the microtip for ankle debridement.Such use could apply a moment to the needle tip and push it against the inside of the needle sheath, causing friction and wear between the 2 parts and the generation of metal debris.

Event Description

During a procedure with the tenex system, metal fragments were generated near the tip of the needle and ejected into the treatment site.The procedure was stopped, and the fragments removed with a separate instrument.There was a 5-10 delay due to the additional action.There were no patient complications.

• 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: 12363895
• MDR Text Key: 268043308
• Report Number: 1000135560-2021-00051
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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