MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-10 for MST MALYUGIN RING SYSTEM MAL-1002-1 manufactured by Microsurgical Technology, Inc..
[113568503]
The ring was removed from the eye, a second malyugin ring assembly was used and surgery was completed. After the device was returned, the malyugin ring assembly passed functional testing with a new ring. The ring used in surgery was deformed and could not be evaluated. Manufacturing records were pulled and the ring was within specification during inspection.
Patient Sequence No: 1, Text Type: N, H10
[113568504]
The customer reported that upon insertion of the malyugin ring, the proximal scroll would not eject fully from the cannula when in the eye. The scroll caught the iris and tore a small fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00022 |
| MDR Report Key | 7674652 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-10 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2018-07-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CECIL CHRISINGER |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| 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 | MST MALYUGIN RING SYSTEM |
| Generic Name | CLIP IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2018-07-10 |
| Returned To Mfg | 2018-06-28 |
| Model Number | MAL-1002-1 |
| Catalog Number | MAL-1002-1 |
| Lot Number | 097119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-10 |