MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for COR-KNOT MINI? 031350 manufactured by Lsi Solutions, Inc..
[124953376]
One cor knot device was unable to load the corknot reload. New corknot was opened to complete the procedure. Product had patient contact but no patient harm. Product is available for return. Manufacturer response for lsi cor knot 4mm, (brand not provided) (per site reporter): notified rep who will send return kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7999218 |
| MDR Report Key | 7999218 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-21 |
| Report Date | 2018-10-11 |
| Date Reported to FDA | 2018-10-11 |
| Date Reported to Mfgr | 2018-10-24 |
| Date Added to Maude | 2018-10-24 |
| 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 | 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 | 3 |
| Brand Name | COR-KNOT MINI? |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2018-10-24 |
| Model Number | 031350 |
| Catalog Number | 031350 |
| Lot Number | 727751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Manufacturer Address | 7796 VICTOR-MENDON RD. VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |