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

Catalog Number 554-1003-001

Device Problem Hole In Material (1293)

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

Event Date 04/23/2013

Event Type  malfunction  

Event Description

Bag had a hole, would not keep vacuum or prime.

Manufacturer Narrative

"the unit was not received from the field for evaluation.It is not possible to verify an assignable cause without evaluating the alleged complaint unit.Insufficient information for a complete investigation.The dhr for lot 08113-04 was reviewed.The units met manufacturing specifications when released and there were no issues related to the complaint.There were (b)(4) units released from lot 08113-04.A review of lot history shows that there were (b)(4) units that failed for functionality.This lot has a failure rate of (b)(4).No significant trend was observed.".

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): AOI, INC.; lake forest CA
• Manufacturer (Section G): .
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3727682
• MDR Text Key: 4322597
• Report Number: 2085033-2014-00276
• 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: Other
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 08113-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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