MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-03-27 for MALYUGIN RING SYSTEM MAL-0002 manufactured by Microsurgical Technology Inc.
[16375217]
(b)(4). The initial processing of this complaint from the customer determined that it was not a reportable incident at the time received 09/12/2012. The device was received with the ring disengaged from the cassette but not damaged. The ring being found to be within specification was functionally tested with the original applicator and passed all tests. There was no original applicator and passed all tests. There was no failure observed during testing and the failure reported could not be duplicated. There was no patient contact.
Patient Sequence No: 1, Text Type: N, H10
[16436206]
The customer reported that the surgeon was unable to hold the ring with the applicator for the malyugin ring system. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2013-00012 |
| MDR Report Key | 3150081 |
| Report Source | 00 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-27 |
| Date of Event | 2012-09-12 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-06-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2013-03-27 |
| Returned To Mfg | 2012-09-17 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | 047569 |
| ID Number | NA |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-03-27 |