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

Catalog Number 554-1003-001

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 08/21/2013

Event Type  malfunction  

Event Description

Plastic tip from micro tip that connects to saline bag connected in usual fashion.On inverting the saline bag for priming, saline leaking from bag that is attached to black cassette.Priming attempted regardless and successful.When foot pedal depressed to ensure cutting device makes proper cutting sound, error on screen indicating "check needle." attempt made to prime micro tip again with same message noted.

Manufacturer Narrative

Unit was received from the field for evaluation.Refer to evaluation # (b)(4)-customer stated "check handpiece" message displayed.Found damage to connector alignment key.Appears customer installed the connector incorrectly.Functioned within all specs when installed properly on demo unit.The dhr for microtip lot 17613-08 was reviewed and showed that the units met manufacturing specifications when released and there were no issues related to the complaint.There were (b)(4) units released from microtip lot 17613-08.A review of lot history showed that there were (b)(4) reported microtip unit failures from this lot.Lot 17613-08 has a failure rate of (b)(4).

• 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: 3727890
• MDR Text Key: 4324833
• Report Number: 2085033-2014-00373
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K123640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial
• Report Date: 01/20/2014

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: 05/31/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 17613-08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2013
• Initial Date Manufacturer Received: 08/21/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2013
• 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