MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-04 for ENDOSTITCH 173016 manufactured by Covidien Lp.
[63831443]
Patient Sequence No: 1, Text Type: N, H10
[63831444]
When using surgidac suture, the needle came off of the device. It was reloaded inside of the patient and then the needle broke off of the suture strand as the device was removed from the trocar. Initially, it was thought the needle was lost in patient's abdomen but found minutes later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6221217 |
| MDR Report Key | 6221217 |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-11-22 |
| Report Date | 2016-12-19 |
| Date Reported to FDA | 2016-12-19 |
| Date Reported to Mfgr | 2016-12-19 |
| Date Added to Maude | 2017-01-04 |
| 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 |
| 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 | ENDOSTITCH |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | MFJ |
| Date Received | 2017-01-04 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J6E1808X |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-04 |