MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-11 for MALYUGIN RING SYSTEM MAL-1002-1 manufactured by Microsurgical Technology, Inc..
[108154753]
Complaint received to mst was the "ring did not deploy". The evaluation of the returned device could not reproduct the failure. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[108154754]
A customer reported that the malyugin ring "would not deploy".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2018-00017 |
| MDR Report Key | 7508537 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-03-28 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2018-01-19 |
| Date Added to Maude | 2018-05-11 |
| 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. ROB RANEY |
| 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 | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2018-05-11 |
| Returned To Mfg | 2018-04-13 |
| Model Number | MAL-1002-1 |
| Catalog Number | MAL-1002-1 |
| Lot Number | 094925 |
| 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 | 2018-05-11 |