MAUDE Adverse Event Report: TENEX HEALTH TENEX HEALTH TX SYSTEM - MICROTIP; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-2003-001

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

The customer disposed of the microtip.Based upon results of similar reported failures and lab testing it is most probable that the immediate cause is material fatigue associated with and/or being caused by user error.It is suspected that non-axial motion by the user or contact with bone/ hard tissue is the primary contributing factor to the needle breaking.Lab testing, to date, has been unable to duplicate needle failure when appropriate axial technique is used in simulated use conditions.

Event Description

Per the information provided, the doctor removed the microtip to evaluate the area being treated and noticed that the needle was sliding out the end of the handpiece.At the same time the distributor noticed the extended length of the device and told the doctor to stop.Total cutting time was 1:20 minutes when the failure occurred.Per the distributor, the doctor was using a good technique going in-line with the elbow, however the distributor could not tell if doctor hit bone with the microtip.Another microtip was opened to complete the procedure.No issues with second microtip.There was no harm, injury, or complication to the patient caused by the failure.The microtip was disposed of by the facility staff.It is not being returned for evaluation.

• Brand Name: TENEX HEALTH TX 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: 6645735
• MDR Text Key: 77702541
• Report Number: 3009750704-2017-00077
• Device Sequence Number: 1
• Product Code: LFL
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other