MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-09 for MALYUGIN RING SYSTEM manufactured by Microsurgical Technology Inc.
[16150107]
During cataract surgery the malyugin ring was left in the eye. A second surgery was required by a retinal surgeon to remove the ring from the eye. The ring was removed without impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16472655]
At the time of this report there was no information available as to the circumstances that lead to the ring being left in the eye. The retinal surgeon initially reported the situation and had no relevant information regarding the actual incident. The ring was sucessfully removed from the patient's eye and the patient was doing well one week post-op.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00023 |
| MDR Report Key | 4904037 |
| Report Source | 05 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-07-10 |
| 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 Contact | MR. ROBERT MAY |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-07-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-09 |