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

Catalog Number 554-1003-001

Device Problem Loss of Power (1475)

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

Event Date 03/22/2013

Event Type  malfunction  

Event Description

Hand piece stopped working shortly after beginning the procedure.

Manufacturer Narrative

The unit is not being returned for evaluation.It is not possible to verify an assignable cause without evaluating the alleged complaint product.Insufficient information for a complete investigation.The dhr for lot 05113-01 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 05113-01.A review of lot history showed that there were (b)(4) reported unit failures for functionality.This lot has a failure rate of (b)(4).No significant trend was observed.A review of the complaint database showed that in the past six (6) months of the complaint open date ((b)(6) 2012 - (b)(6) 2013) there were ten (b)(4) reported complaints from this facility.Per the sales rep, the customer was not using a compression cuff, which can lower the psi of the bag.This cause cannot be verified.The rep also stated that when units stop cutting, the staff immediately installs a new cartridge without trying to troubleshoot the unit.The rep has since in-serviced the staff.Since the staff retrain, the frequency of complaints from this facility has decreased.(one complaint reported).

• 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: 3728023
• MDR Text Key: 18571723
• Report Number: 2085033-2014-00261
• 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
• 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: 01/31/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 05113-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2013
• 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