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 06/08/2017

Event Type  Injury  

Manufacturer Narrative

The customer reported that the needle separated from the microtip.Needle separation was confirmed upon receipt of the handpiece.The needle was returned alongside the microtip.The case nose has a crack, which was caused by the side to side motion from the user.Due to the state in which the device was received functional testing could not be performed.Based upon customer report doctor was using hand piece in side to side motion causing damage to the case nose and break of needle.

Event Description

Per the information provided by the distributor, the doctor was using the device with a swiping motion toward the end of the procedure.As he was removing the microtip from the incision site the doctor and distributor noticed the needle was loose.The doctor was able to put his thumb on the needle as he was removing the instrument the patient, thereby removing the needle at the same time.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: 6696222
• MDR Text Key: 79354326
• Report Number: 3009750704-2017-00091
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/08/2017

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: 02/28/2018
• Device Catalogue Number: 554-2003-001
• Device Lot Number: 06517-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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