MAUDE Adverse Event Report: AOI, INC. TXI 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 04/03/2013

Event Type  malfunction  

Event Description

There is a hole in the bag, it never primed.

Manufacturer Narrative

Unit was received for evaluation.Refer to evaluation # mt00108 - customer stated "hole" in collection bag prevented priming.Hole is bag vent and is intended to be there.Unit primed successfully on multiple attempts.Unit function properly under all three power levels.Disassembled.No internal visible defects found.The dhr for lot 06513-02 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 06513-02.A review of lot history showed that there were (b)(4) units that failed for functionality.This lot has a failure rate of (b)(4).

• Brand Name: TXI 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: 3727676
• MDR Text Key: 4322596
• Report Number: 2085033-2014-00274
• 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: 06513-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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