MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-21 for MALYUGIN RING SYSGTEM MAL-0001 MAL-001 manufactured by Microsurgical Technology, Inc..
[3323634]
During the removal of the malyugin ring system using a sinskey hook and the inserter, the ring's glue joint fractured and broken end of the ring "strummed" the zonules. The procedure was completed as planned and there was no permanent damage.
Patient Sequence No: 1, Text Type: D, B5
[10608393]
At the time of this report, the device has not been returned for eval. The surgeon indicated that he used a sinskey hook to remove the ring. The directions for use warn against the use of this hook. There was no decentration of the capsule or lens noticed during follow up with the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2013-00009 |
| MDR Report Key | 3027813 |
| Report Source | 05 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-01-21 |
| Date Mfgr Received | 2013-02-21 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-04-01 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSGTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2013-03-21 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-001 |
| Lot Number | 048150 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2013-03-21 |