MALYUGIN RING SYSTEM MAL-0001-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-19 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..

Event Text Entries

[5613183] 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.
Patient Sequence No: 1, Text Type: D, B5


[13074635] 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 first of five reports.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3019924-2015-00010
MDR Report Key4632496
Report Source05,06
Date Received2015-03-19
Date of Report2015-03-19
Date of Event2015-02-05
Date Mfgr Received2014-02-17
Device Manufacturer Date2014-11-01
Date Added to Maude2015-05-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street8415 154TH AVE., N.E.
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4255560544
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALYUGIN RING SYSTEM
Generic NameIRIS CLIP RETRACTOR
Product CodeHOC
Date Received2015-03-19
Returned To Mfg2015-02-27
Model NumberMAL-0001-1
Catalog NumberMAL-0001-1
Lot Number065149
Device Expiration Date2017-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICROSURGICAL TECHNOLOGY, INC.
Manufacturer AddressREDMOND WA US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-19

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