MAUDE Adverse Event Report: AOI, INC TX1 TISSUE REMOVAL SYSTEM - CONSOLE; ULTRASONIC SURGICAL ASPIRATOR

Catalog Number 554-0000-000

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

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

Event Date 10/25/2013

Event Type  malfunction  

Event Description

Keeps cutting out and has to be restarted.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - CONSOLE
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): AOI, INC; lake forest CA
• Manufacturer Contact: vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3745379
• MDR Text Key: 4220484
• Report Number: 2085033-2014-00427
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2014

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 Catalogue Number: 554-0000-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/01/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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