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

Catalog Number 554-1003-001

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 08/05/2013

Event Type  malfunction  

Event Description

Lost cutting power.

Manufacturer Narrative

Unit was received from the field for evaluation.Refer to evaluation # (b)(4) - unit primed and functioned initially.Cutting power stopped after 15 seconds.Upon internal inspection, found cracked piezo crystal.Poor sweep.Cracked crystal resulted in poor performance which was detected by console and power was shut down.The dhr for lot 14413-05 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 14413-05.There were (b)(4) reported unit failures due to functionality for this lot.This lot has a failure rate of (b)(4).

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR MGI
• Manufacturer (Section D): AMERICAN OPTISURGICAL, INC.; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3747867
• MDR Text Key: 4551817
• Report Number: 2085033-2014-00361
• 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: 08/15/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2013
• 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