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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Quit working during procedure.

Manufacturer Narrative

Unit not returned for eval; updated mdr flowchart completed; this lot has a (b)(4) complaint rate; dhr review does not indicate a mfg error; (b)(4) complaints from this facility - could be a new facility with a training issue; without an eval there is no determination of malfunction cause- refer to capa (b)(4) initiated october 2012 to investigated the numerous stopped working issues ((b)(4)-0003,.A was released with results for the verification effectiveness of a larger electrode bend radius of the microtip; the increased electrode bend radius indicated improved output of the manufacturing process and elimination of failures due to electrode breakage.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM- MICROTIP
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR MGI
• Manufacturer (Section D): AMERICAN OPTISURGICAL, INC.; 25501 arctic ocean; lake forest CA 92630
• Manufacturer (Section G): AMERICAN OPTISURGICAL, INC.; 25501 arctic ocean; lake forest CA 92630
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3726594
• MDR Text Key: 4305136
• Report Number: 2085033-2014-00233
• 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: 12/31/2013
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 00713-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2013
• 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