MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-01 for MST MALYUGIN RING MAL-0002-1 MAL-0002 manufactured by Microsurgical Technology Inc.
[25387272]
The ring was returned with a fractured glue joint and showing signs of being squeezed or pinched during use. The physician indicated that he was using a method of removal that is contrary to the instructions for use. The doctor imployed the use of the osher malyugin manipulator rather than the injector to remove the ring from the eye.
Patient Sequence No: 1, Text Type: N, H10
[25387273]
The surgeon reported that when he attempted to remove the malyugin ring from the patient's eye with the osher/malyugin manipulator the ring broke at the glue joint. There was no impact to the patient and the ring was removed from the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2015-00028 |
| MDR Report Key | 5048468 |
| Date Received | 2015-09-01 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-09-01 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | MST MALYUGIN RING |
| Generic Name | IRIS RETRACTOR CLIP |
| Product Code | HOC |
| Date Received | 2015-09-01 |
| Returned To Mfg | 2015-08-07 |
| Model Number | MAL-0002-1 |
| Catalog Number | MAL-0002 |
| Operator | PHYSICIAN |
| 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 | 2015-09-01 |