MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-28 for ENDOSTITCH 173016 manufactured by Covidien (medtronic).
[60920250]
Patient Sequence No: 1, Text Type: N, H10
[60920251]
The endostitch would release the needle when not wanted to release and does not release the needle when wanted to release.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6128550 |
| MDR Report Key | 6128550 |
| Date Received | 2016-11-28 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-09-19 |
| Report Date | 2016-10-18 |
| Date Reported to FDA | 2016-10-18 |
| Date Reported to Mfgr | 2016-10-18 |
| Date Added to Maude | 2016-11-28 |
| 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 | ENDOSTITCH |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | MFJ |
| Date Received | 2016-11-28 |
| Returned To Mfg | 2016-10-18 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J6G0087X |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN (MEDTRONIC) |
| Manufacturer Address | 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-28 |