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..
[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
| Report Number | 3019924-2015-00010 |
| MDR Report Key | 4632496 |
| Report Source | 05,06 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2014-02-17 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 8415 154TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-03-19 |
| Returned To Mfg | 2015-02-27 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| Lot Number | 065149 |
| Device Expiration Date | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-19 |