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

Catalog Number 554-0000-000

Device Problem Failure to Power Up (1476)

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

Event Date 08/09/2013

Event Type  malfunction  

Event Description

This console will not power up.We changed the fuses but it still won't power up.

Manufacturer Narrative

The console was received from the field for evaluation.Refer to evaluation #(b)(4) - unit fails to turn on.Power inlet fuses are functional normal.Upon internal inspection, found power supply "slow-blow" fuse blown.Replaced fuse.All voltages functioning normally indicating cause of blown fuse.Recommend perform quality checks and return to customer.Replaced power supply 3.5 amp slow-blow fuse.Checked and tested.Units functions within all specs.The dhr for the console (sn (b)(4)) was reviewed and showed that the unit met manufacturing specifications when released.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - CONSOLE
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR MGI
• Manufacturer (Section D): AOI, INC.; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3664204
• MDR Text Key: 17153279
• Report Number: 2085033-2014-00366
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• 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: 01/18/2014

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: 08/13/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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