MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-16 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology Inc.
[100473218]
The surgeon alleged that the ring came apart when retrieving from the eye. There was no patient impact and the surgery was completed successfully. No device was returned for evaluation. Rings from the same lot were evaluated but cause was not able to be determined. This is the fourth of four reports.
Patient Sequence No: 1, Text Type: N, H10
[100473219]
The user alleged that the ring came apart at the glue bead while removing from the eye. There was no patient impact and the surgery was completed successfully. This is the fourth of four reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00012 |
| MDR Report Key | 7278870 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-18 |
| Device Manufacturer Date | 2017-03-23 |
| Date Added to Maude | 2018-02-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROB RANEY |
| 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 |
| 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 | 2018-02-16 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| Lot Number | 087322 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-02-16 |