MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-03 for ENDO STITCH AUTO SUTURE 173016 manufactured by Covidien.
[6071346]
Device was loaded with a 0-surgidac suture to begin pt closure. Device was to be reloaded and noted that previous suture was broken. Half of the suture remained in the device and the other half was found on the pt field and removed. Broken suture removed from device and attempted to reload device with 2-0 surgidac suture. Device received suture but would not close, articulate or operate properly. Device removed from field and replaced with new device to complete case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043892 |
| MDR Report Key | 4905595 |
| Date Received | 2015-07-03 |
| Date of Report | 2015-07-03 |
| Date Added to Maude | 2015-07-13 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH AUTO SUTURE |
| Generic Name | SUTURING DEVICE |
| Product Code | MFJ |
| Date Received | 2015-07-03 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J5C0129X |
| ID Number | (01) 10884521100008 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-03 |