MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-09 for MALYUGIN RING SYSTEM MAL-0001-1 manufactured by Microsurgical Technology, Inc..
[5203761]
The doctor was ejecting the malyugin ring from the cannula and as soon as the glued portion was ejected he noticed it was broken. As the ring wasn't fully ejected he was able to just pull it back into the cannula and remove it. A second ring was used to complete surgery and there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2014-00055 |
| MDR Report Key | 4358143 |
| Report Source | 05,06 |
| Date Received | 2014-12-09 |
| Date of Report | 2014-12-05 |
| Date Mfgr Received | 2014-11-10 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-01-05 |
| 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 Street | 8415 154TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| 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 | 2014-12-09 |
| Returned To Mfg | 2014-11-24 |
| Model Number | MAL-0001-1 |
| Catalog Number | MAL-0001-1 |
| Lot Number | 058895 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-09 |