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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. 22G CURVED ASPIRATOR, .3 MM PORT; BIMANUAL ASPIRATION TIP
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MICROSURGICAL TECHNOLOGY, INC. 22G CURVED ASPIRATOR, .3 MM PORT; BIMANUAL ASPIRATION TIP Back to Search Results
Model Number DU-02355
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Event Description
The facility reported that "diamond particles were visible in the anterior chamber after using the diamond dusted aspiration tip".This was alleged to have caused prolonged inflammation in the patient's eye.
 
Manufacturer Narrative
The returned device was not "diamond dusted".Mst does not manufacture diamond dusted tips.The returned tip was a capsule polished bi-manual aspiration tip that showed normal signs of use; however, did not have any loose particulate or residue that could have been introduced into the eye.It is most likely that the debris was surgical residue from previous use that was not thoroughly cleaned from the tip.
 
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Brand Name
22G CURVED ASPIRATOR, .3 MM PORT
Type of Device
BIMANUAL ASPIRATION TIP
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key4193813
MDR Text Key18291967
Report Number3019924-2014-00045
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 10/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDU-02355
Device Catalogue NumberDU-02355
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/06/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/10/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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