MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-29 for AUTO STITCH 173016 manufactured by Covidien.
[5331017]
Covidien endo stitch auto suture device would not release needle upon removal from patient. The needle was broken during an attempt to remove it with a retained portion of the needle still remaining in the device. A subsequent "like" device was utilized for completion of the surgical procedure. Reason for use: laparoscopic diaphragmatic plication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040566 |
| MDR Report Key | 4484013 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-29 |
| Date Added to Maude | 2015-02-05 |
| 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 | AUTO STITCH |
| Generic Name | ENDO STITCH AUTO SUTURE |
| Product Code | MFJ |
| Date Received | 2015-01-29 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J4L0634X |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD 02048 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |