MAUDE Adverse Event Report: TENEX HEALTH TX2 MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 554-2003-001

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  malfunction  

Event Description

Defect ¿ the sheath on the microtip came loose as it was being removed from patient.The attending informed the technologist that the microtip of the tenex probe detached during a procedure on a patient.There was no harm to patient.This is the second such occurrence in two months - tx 1 in (b)(6) 2016 , tx2 in (b)(6) 2016 - difference is the length of the needle.

• Brand Name: TX2 MICROTIP
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH; 26902 vista terrace; lake forest CA 92630
• MDR Report Key: 6306836
• MDR Text Key: 66692347
• Report Number: 6306836
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 554-2003-001
• Device Lot Number: 31416-05
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR