MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-22 for ENDOSTITCH 173016 manufactured by Covidien.
[55337208]
Patient Sequence No: 1, Text Type: N, H10
[55337209]
There was difficulty loading the suture. Once suture was loaded and inserted the needle was used, but fell off of the endostitch on the first pass through the tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5969603 |
| MDR Report Key | 5969603 |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-14 |
| Report Date | 2016-09-21 |
| Date Reported to FDA | 2016-09-21 |
| Date Reported to Mfgr | 2016-09-21 |
| Date Added to Maude | 2016-09-22 |
| 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 |
| Product Code | OCU |
| Date Received | 2016-09-22 |
| Catalog Number | 173016 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-22 |