MAUDE Adverse Event Report: TENEX HEALTH TXI TISSUE REMOVAL SYSTEM - CONSOLE; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-0000-000

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The patient was replaced under general anesthesia prior to the device being turned to "on".When the medical staff tried to turn on the console the device did not work, the screen would not turn on.Another console was obtained and the procedure was completed without further incident/failure.There was no complication or injury to the patient caused by the delay.The delay in surgery was greater than 30 minutes due to the failure of the device.

Manufacturer Narrative

The customer representative sent the reported failure information to the manufacturer on (b)(4) 2015.Information in the original complaint documentation stated that the incident occurred in (b)(6) 2015.Communication with the customer found that the failure occurred in (b)(6) 2015 and the customer reported the console had never work, it was the first time they tried to use the device since they receive it.Review of the shipping documentation found the console had been shipped to the customer in (b)(4) 2013.Evaluation of the device the aspiration and irrigation levels were out of specification and that the touchscreen was unresponsive.A cracked solder joint was found on the main board, which caused the reported and found screen failures.The main board was replaced and the aspiration and irrigation levels were adjusted back into specification.The cracked solder joint caused the failure.It is unknown what caused the solder joint to crack.The possibilities are a mechanical impact or an issue during manufacturer.Consoles to through a functionality check before they are placed into stock for shipment.As the patient was under general anesthesia and there was a delay over 30 minutes this is considered a reportable event by the manufacturer.

• Brand Name: TXI TISSUE REMOVAL SYSTEM - CONSOLE
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): TENEX HEALTH; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 4844595
• MDR Text Key: 18387588
• Report Number: 3009750704-2015-00587
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123640
• 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: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 554-0000-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR