MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for COR-KNOT MINI 031350 manufactured by Lsi Solutions.
[36488024]
Patient Sequence No: 1, Text Type: N, H10
[36488025]
Device would not load properly; cor knots all out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5382483 |
| MDR Report Key | 5382483 |
| Date Received | 2016-01-21 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-12-17 |
| Report Date | 2015-12-23 |
| Date Reported to FDA | 2015-12-23 |
| Date Reported to Mfgr | 2015-12-23 |
| Date Added to Maude | 2016-01-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | COR-KNOT MINI |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | GAS |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2015-12-21 |
| Model Number | 031350 |
| Catalog Number | 031350 |
| Lot Number | 258347 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | 7796 VICTOR-MENDON RD VICTOR, NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-21 |