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

Catalog Number 554-1003-001

Device Problem Loss of Power (1475)

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

Event Date 11/07/2013

Event Type  malfunction  

Event Description

Tx1 quit working - no sound when pedal pressed.

Manufacturer Narrative

The unit will not be returned for eval because it was disposed of.It is not possible to verify an assignable cause w/o evaluating the alleged complaint unit.Insufficient info for a complete investigation.The dhr for microtip lot 20713-06 was reviewed and showed that the units met mfg 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
• Manufacturer (Section D): AOI, INC; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3670086
• MDR Text Key: 20657865
• Report Number: 2085033-2014-00459
• 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: 06/30/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 20713-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2013
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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