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

Catalog Number 554-2003-001

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

The customer reported that the needle had separated from the microtip.Needle separation was confirmed upon receipt of the handpiece.Due to the state in which the device was received functional testing could not be performed.The hypodermic needle had separated at the braze joint.This is the highest stress point along the length of the needle.There was no indication of severe side loading or contact with hard tissue.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 and bending of the needle during use contributed 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, indicating the failure is not related to material defect.

Event Description

Per the information provided, this was the second time the doctor had used the device.He was doing a fibroma, working around the arch of the foot.The needle was bending a little bit and the needle broke.Cutting time at time of needle separation was 1:15 minutes.As the doctor removed the microtip from the patient's foot and he noticed that the needle was halfway out of the shaft.The needle did not lodge in the patient, it remained in the microtip as the device was removed from the patient.A second microtip was obtained and the procedure completed with that device.There was a 3 minute delay while devices were switched out and the patient was under general anesthesia.There was no harm, injury or complication to the patient caused by the failure.

• 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: 6774508
• MDR Text Key: 82109856
• Report Number: 3009750704-2017-00109
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 554-2003-001
• Device Lot Number: 11017-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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: 49 YR
• Patient Weight: 70