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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY MALYUGIN RING SYSTEM; IRIS CLIP RETRACTOR
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MICROSURGICAL TECHNOLOGY MALYUGIN RING SYSTEM; IRIS CLIP RETRACTOR Back to Search Results
Model Number MAL-1002-1
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2019
Event Type  malfunction  
Manufacturer Narrative
Complaint received by mst was the "malyugin ring did not deploy correctly prior to insertion." the evaluation of the returned device could not reproduct the failure.The complaint could not be confirmed.
 
Event Description
Per customer reported that "malyugin ring did not deploy correctly prior to insertion.No patient contact or patient information known at this time.".
 
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Brand Name
MALYUGIN RING SYSTEM
Type of Device
IRIS CLIP RETRACTOR
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY
8415 154th ave ne
redmond WA 98052
Manufacturer (Section G)
MICROSURGICAL TECHNOLOGY
8415 154th ave ne
redmond WA 98052
Manufacturer Contact
cecil chrisinger
8415 154th ave ne
redmond, WA 98052
4252846094
MDR Report Key8457137
MDR Text Key140174450
Report Number3019924-2019-00001
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 user facility
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2021
Device Model NumberMAL-1002-1
Device Catalogue NumberMAL-1002-1
Device Lot Number105094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2018
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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