MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-27 for MALYUGIN RING SYSTEM MAL-1002-1 manufactured by Microsurgical Technology.
[140174450]
Complaint received by mst was the "malyugin ring did not deploy correctly prior to insertion. " 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
[140174451]
Per customer reported that "malyugin ring did not deploy correctly prior to insertion. No patient contact or patient information known at this time. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2019-00001 |
| MDR Report Key | 8457137 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2019-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CECIL CHRISINGER |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252846094 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY |
| 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 | 2019-03-27 |
| Returned To Mfg | 2019-02-28 |
| Model Number | MAL-1002-1 |
| Catalog Number | MAL-1002-1 |
| Lot Number | 105094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-27 |