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

Catalog Number 554-1003-001

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2013

Event Type  malfunction  

Event Description

While priming handpiece, collection bag filled up with saline, there was leaking out of the handpiece tubing near the tip but it said priming was successful.When we went to do the 10 sec test, the handpiece would not work at all and the screen said check handpiece.All connection were checked and test was attempted again but handpiece would not work.

Manufacturer Narrative

Unit was received from the field for eval.(b)(4) - observed severely bent connector pins.Upon testing received the "check hp" error message.Unit was disassembled to verify internal components.No damage or defects were found.Error determined to be a direct result of the bent connector pins.There was no problem with the collection bag.This malfunction can occur when the cassette is not inserted into the console securely.The dhr for microtip lot # 26813-01 was reviewed and showed that the units met mfr specifications when released and there were no issues related to the complaint.There were (b)(4) units released from microtip lot # 26813-01.(b)(4).Per the sr clinical manager most of the malfunctions observed at the facility were due to customer misuse.(b)(4).

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Type of Device: ULTRASOUND SURGICAL ASPIRATOR
• Manufacturer (Section D): AMERICAN OPTISURGICAL, INC.; lake forest CA
• Manufacturer Contact: 26902 vista terrace; lake forest, CA 92630 ; 9494547500
• MDR Report Key: 3670152
• MDR Text Key: 4346630
• Report Number: 2085033-2014-00473
• 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: 07/31/2014
• Device Catalogue Number: 554-1003-001
• Device Lot Number: 26813-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2013
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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