MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for ENDO360 ECN-C130T manufactured by Endoevolution, Llc.
[85636609]
Patient Sequence No: 1, Text Type: N, H10
[85636610]
During a laparoscopic biliopancreatic diversion with duodenal switch single anastomosis with hiatal hernia repair procedure, the endo360 suture needle spontaneously popped off the suture while in the patient laparoscopically. The surgeon was able to retrieve the needle, and the procedure continued without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6854605 |
| MDR Report Key | 6854605 |
| Date Received | 2017-09-11 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-03-02 |
| Report Date | 2017-08-25 |
| Date Reported to FDA | 2017-08-25 |
| Date Reported to Mfgr | 2017-08-25 |
| Date Added to Maude | 2017-09-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | ENDO360 |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GCJ |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-03-20 |
| Catalog Number | ECN-C130T |
| Lot Number | 160224-53 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ENDOEVOLUTION, LLC |
| Manufacturer Address | 10 COMMERCE WAY SUITE 5 RAYNHAM MA 02767 US 02767 |
| Brand Name | ENDO360 |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-03-20 |
| Catalog Number | ECN-C130T |
| Lot Number | 160224-53 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOEVOLUTION, LLC |
| Manufacturer Address | 10 COMMERCE WAY SUITE 5 RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-11 |