MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for COR-KNOT 031082 manufactured by Lsi Solutions, Inc..
[123350031]
Cor-knot misfired during avr. It fired and then cut the structure behind the clip and suture came out. Another cor-knot was opened and used. The 2nd device worked as expected. There was no harm to the patient. The incident is being reported since the surgeon, who has been using cor-knot for years, had another misfire incident on (b)(6) 2018 at our facility. Both incidents have been reported to the manufacturer, both devices returned to the manufacturer. Both are being reported to fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080414 |
| MDR Report Key | 7946940 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-09-21 |
| Date Added to Maude | 2018-10-09 |
| 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 |
| 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 |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC POLYESTER |
| Product Code | GAS |
| Date Received | 2018-10-05 |
| Returned To Mfg | 2018-09-25 |
| Catalog Number | 031082 |
| Lot Number | 725498 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-05 |