MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-23 for MALYUGIN RING SYSTEM MAL-0002-1 manufactured by Microsurgical Technology, Inc..
[4976355]
As the malyugin ring was being removed from the eye the glue joint broke. There was no impact to the pt and the procedure was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
[12463220]
The device was returned with the scrolls of the ring wrapped around the cannula of the inserter indicating that the ring had been retracted to far into the cannula causing the glue joint to fail. The instructions for use indicate to retract the ring to the edge of the cannula only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2014-00047 |
| MDR Report Key | 4229899 |
| Report Source | 06 |
| Date Received | 2014-10-23 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-09-25 |
| Date Mfgr Received | 2014-09-26 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-11-07 |
| 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 | 2014-10-23 |
| Returned To Mfg | 2014-10-21 |
| Model Number | MAL-0002-1 |
| Catalog Number | MAL-0002-1 |
| Lot Number | 062755 |
| Device Expiration Date | 2017-07-01 |
| 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 | 1. Other | 2014-10-23 |