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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOI, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; ULTRASONIC SURGICAL ASPIRATOR MGI
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AOI, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; ULTRASONIC SURGICAL ASPIRATOR MGI Back to Search Results
Catalog Number 554-1003-001
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2013
Event Type  malfunction  
Event Description
Used as second device after first one did not pass first process.This one did pass the first process but than gave up.Aborted and had to use a 3rd device.
 
Manufacturer Narrative
Product not returned due to pt contact; this lot has (b)(4) functional complaints ((b)(4) not working, (b)(4) priming); the lot overall has a (b)(4)complaint rate; there is no significant complaint trend; dhr's were reviewed - there is no info to suggest this lot would have a higher amount of problems than a lot with a low percentage.Cause for failure cannot be determined.
 
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Brand Name
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
Type of Device
ULTRASONIC SURGICAL ASPIRATOR MGI
Manufacturer (Section D)
AOI, INC.
lake forest CA
Manufacturer Contact
26902 vista terrace
lake forest, CA 92630
9494547500
MDR Report Key3726630
MDR Text Key4272680
Report Number2085033-2014-00209
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123640
Number of Events Reported1
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 Number554-1003-001
Device Lot Number34712-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2013
Initial Date FDA Received01/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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