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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 Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 09/30/2013
Event Type  malfunction  
Event Description
Vacuum failed and bag was leaking water.Microtip was accidentally thrown away.
 
Manufacturer Narrative
This microtip unit was disposed of.It is not possible to verify as assignable cause for the unit failure without evaluating the alleged complaint unit.Insufficient information for a complete investigation.The dhr for microtip lot 19713-04 was reviewed and showed that the units met manufacturing specifications when released and there were no issues related to the complaint.(b)(4).
 
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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 Key3670188
MDR Text Key17153745
Report Number2085033-2014-00401
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 01/21/2014
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 Date06/30/2014
Device Catalogue Number554-1003-001
Device Lot Number19713-04
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/16/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/01/2013
Initial Date FDA Received01/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2013
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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