MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for COR-KNOT MINI DEVICE manufactured by Lsi Solutions.
[58758714]
Corknot device would not cut suture when the trigger was fired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065658 |
| MDR Report Key | 6063226 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-10-19 |
| Date Added to Maude | 2016-10-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COR-KNOT MINI DEVICE |
| Generic Name | COR-KNOT |
| Product Code | GAS |
| Date Received | 2016-10-26 |
| Returned To Mfg | 2016-10-26 |
| Lot Number | 414989 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-26 |