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

Catalog Number 554-1003-001

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/16/2013

Event Type  malfunction  

Event Description

Before procedure started, hand piece leaked saline at a very fast rate from the cartridge in console during priming procedure.Hand piece was replaced with a new one and it functioned properly.

Manufacturer Narrative

Unit was received from the field for evaluation.Refer to evaluation # (b)(4) - unit were received opened.Found damage to molded connector housing on alignment key.Appears customer is forcing the connector with the arrow facing up instead of towards the red indicator dot on the unit.Units functioned within all specs with connector installed properly.Recommend schedule retraining of customer on proper installation of the connector.The dhr for microtip lot 16513-04 was reviewed and showed that the units met manufacturing specifications when released and there were no issues related to the complaint.(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: 3670171
• MDR Text Key: 18305014
• Report Number: 2085033-2014-00395
• 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: 01/21/2014

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: 16513-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2013
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2013
• 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