MAUDE Adverse Event Report: TENEX HEALTH TX1 TISSUE REMOVAL SYSTEM - CONSOLE; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-0000-000

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492); Overfill (2404)

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

Event Date 01/28/2014

Event Type  malfunction  

Event Description

When trying to prime water leaked everywhere, bag overfilled.Opened a 2nd kit tried to prime.Same thing happened.Contacted rep, however he was unavailable.Contacted customer support and opened 3rd kit and it would not prime while i was on the phone with (b)(6).

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - CONSOLE
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): TENEX HEALTH; lake forest CA 92630
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3902894
• MDR Text Key: 4426733
• Report Number: 2085033-2014-00551
• 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: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2014

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 Expiration Date: 07/25/2013
• Device Catalogue Number: 554-0000-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1