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

Catalog Number 554-1003-001

Device Problems Hole In Material (1293); Failure to Prime (1492)

Patient Problem No Information (3190)

Event Date 07/08/2013

Event Type  malfunction  

Event Description

Failed to prime due to a hole in the pressure cuff.

Manufacturer Narrative

"the unit was received from the field for evaluation.Refer to evaluation #(b)(4): hp 1 - unit primed and functioned properly on test unit test002.Could not duplicate any malfunction.Hp 2 - customer stated check handpiece.Microtip was not returned, only packaging.Note on box stated scrub nurse discarded by mistake.Could not verify the customer's complaint of failed prime.The dhr for microtip lot 14413-05 was reviewed and showed that the units met manufacturing specifications when released and there were no issues related to the complaint.(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: 3664205
• MDR Text Key: 4201514
• Report Number: 2085033-2014-00367
• 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: 04/30/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 14413-05
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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