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 Information (3190)

Event Date 11/01/2013

Event Type  malfunction  

Event Description

Water leaking out of bag and hand device.

Manufacturer Narrative

Unit received from the field for evaluation.Refer to # (b)(4) - leaking fluid at case nose, case body joint.Insufficient seal at glue joint - causes unit to fail vacuum test.On (b)(4) 2014 the dhr for microtip lot 21813-01 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 microtip lot #21813-01.A review of lot history showed that there were two reported microtip unit failures.This was the first reported complaint of this nature within lot 21813-01.(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: 3670140
• MDR Text Key: 17153744
• Report Number: 2085033-2014-00430
• 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: 06/30/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 21813-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2013
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2013
• 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