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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. MALYUGIN RING SYSTEM; IRIS CLIP RETRACTOR
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MICROSURGICAL TECHNOLOGY, INC. MALYUGIN RING SYSTEM; IRIS CLIP RETRACTOR Back to Search Results
Model Number MAL-0001-1
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2015
Event Type  malfunction  
Event Description
The facility reported that in the past few weeks they have had three malyugin rings break in the eye during removal from the eye.There was no impact to the pt's.
 
Manufacturer Narrative
The facility reported that they had disposed of the broken rings and that they would be returning the remaining unused portion of the lot for eval.The initial visual inspection of the returned rings indicated that the product meets spec.During an on sight visit the surgeon reported that she was using a method of removal that was not per the directions for use.As a result of the investigation it was determined the five rings had broken.This is the second of five reports.
 
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Brand Name
MALYUGIN RING SYSTEM
Type of Device
IRIS CLIP RETRACTOR
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key4632495
MDR Text Key19404676
Report Number3019924-2015-00011
Device Sequence Number1
Product Code HOC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2017
Device Model NumberMAL-0001-1
Device Catalogue NumberMAL-0001-1
Device Lot Number065149
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received02/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
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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