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

Catalog Number 554-1003-001

Device Problems Loss of Power (1475); Positioning Problem (3009)

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

Event Date 08/14/2013

Event Type  malfunction  

Event Description

Power failed.Needle would not move.

Manufacturer Narrative

Unit was received from the field for evaluation.Refer to evaluation # (b)(4).Unit primed and functioned within all specifications.Could not duplicate malfunction.Found damaged connector key.Customer installed connector with improper key alignment and forced it in.Customer training issue.The dhr for microtip lot 15413-03 was reviewed and showed that the units met manufacturing specifications when released and there were no issues related to the complaint.There were (b)(4) units released from lot 15413-03.A review of lot history showed that there were (b)(4) reported microtip unit failures.Lot of 15413-03 has a failure rate of (b)(4).

• Brand Name: TX1 TISSUE REMOVAL SYSTEM-MICROTIP
• 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: 3727872
• MDR Text Key: 4327668
• Report Number: 2085033-2014-00372
• 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: 01/18/2014

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 Expiration Date: 04/30/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 15413-03
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/06/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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