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

Catalog Number 554-1003-001

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

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

Event Date 06/07/2013

Event Type  malfunction  

Event Description

The kit lost power and stopped working during the procedure.Had to use another kit.

Manufacturer Narrative

The microtip unit was not returned for evaluation.It is not possible to verify an assignable cause for the unit failure without evaluating the alleged complaint product.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.There were (b)(4) reported microtip unit failures from this lot.Lot 08113-04 has a failure rate of (b)(4).

• Brand Name: TX1 TISSUE REMOVAL SYSTEM-MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR
• Manufacturer (Section D): AOI, INC.; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3727878
• MDR Text Key: 18310059
• Report Number: 2085033-2014-00315
• 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: 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: 06/19/2013
• 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