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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 Type  malfunction  
Event Description
It was reported that a small piece of plastic was injected into the eye with a malyugin ring.Reporting site indicated that the doctor retrieved the plastic and that there was no patient impact.
 
Manufacturer Narrative
Analysis of particle to date is inconclusive as to origin.It is unlikely that this particle came from the malyugin ring system.Visually the particle does not match the malyugin ring, and the injector system does not show evidence of missing pieces.
 
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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 Key4357959
MDR Text Key5112801
Report Number3019924-2014-00058
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 Other
Remedial Action Replace
Type of Report Initial
Report Date 12/16/2014
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 Date09/01/2017
Device Model NumberMAL-0001-1
Device Catalogue NumberMAL-0001-1
Device Lot Number063889
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/05/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2014
Initial Date FDA Received12/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2014
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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