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

Catalog Number 554-0000-000

Device Problem Failure to Power Up (1476)

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

Event Date 05/03/2013

Event Type  malfunction  

Event Description

Machine wouldn't turn on/boot up.

Manufacturer Narrative

Unit was received from the field for evaluation.Refer to evaluation # (b)(4) - verified console would not boot up.Technician noted that the top enclosure had two protrusions as the case screws were installed improperly.Appeared customer's biomed department opened the console.Upon internal inspection it was determined that two ground wire crimp terminals were damaged.Could not verify cause.Possibly used as a test point by biomed department.Recommend replace ground wire crimp terminals and top enclosure.Recommend re-adjust and test.Repaired two internal ground wires.Replaced top enclosure with lot# 34611-02.Recalibrated, tested and adjusted.The dhr for the console (s/n (b)(4) was reviewed.The console failed during burn in and would not boot up ((b)(4)).The (b)(4) board was replaced and the console was qc tested before release.The unit met manufacturers specifications before release.A review of console history (s/n (b)(4)) showed that this was the only reported complaint originating from this console.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - CONSOLE
• 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: 3727620
• MDR Text Key: 20009210
• Report Number: 2085033-2014-00305
• 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 Catalogue Number: 554-0000-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1