MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2015-06-19 for MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology Inc.
[5847956]
The facility reported that two weeks post-op after operating on a patient with a dense cataract and a small pupil that it was discovered that a piece of the malyugin ring had been retained in the eye. The piece was removed and there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[13471709]
Only a portion of the ring was returned for evaluation. The piece that was returned showed signs of being abused with one end of the piece having cut marks most likely from scissors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00021 |
| MDR Report Key | 4857526 |
| Report Source | 05,06,08 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-19 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-05-21 |
| Device Manufacturer Date | 2015-01-14 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| 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 |
| 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 | 2015-06-19 |
| Returned To Mfg | 2015-06-16 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| Lot Number | 066505 |
| Device Expiration Date | 2018-01-01 |
| Device Availability | R |
| Device Age | 4 MO |
| 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. Required No Informationntervention | 2015-06-19 |