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

Catalog Number 554-1003-001

Device Problem Loss of Power (1475)

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

Event Date 01/03/2013

Event Type  malfunction  

Event Description

Hand piece failed at 1.05 minutes into procedure without any negative outcomes.

Manufacturer Narrative

Weekly complaint meeting held, close complaints (b)(4) and refer to capa (b)(4), this capa is governing the investigation to determine how to improve duration for the handpiece to stop working would only provide a minor inconvenience to both the doctor and the patient.There is no harm in the unit if it stops cutting.This lot is performing within an acceptable percentage rate and requires no add'l investigation.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASONIC SURICAL ASPIRATOR
• Manufacturer (Section D): AOI, INC.; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3726645
• MDR Text Key: 4306222
• Report Number: 2085033-2014-00204
• 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: 01/31/2013
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 28912-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2012
• 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