MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for AUTOSUTURE ENDO STITCH 173016 manufactured by Covidien.
[38245075]
Patient Sequence No: 1, Text Type: N, H10
[38245076]
During laparoscopic gastric bypass, the endostitch did not work properly. The needle didn't pass from end to the other, but got stuck in the adipose tissue. The needle was retrieved and the device was isolated. The patient did not sustain any harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5438191 |
| MDR Report Key | 5438191 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-11 |
| Date of Event | 2015-12-16 |
| Report Date | 2016-02-11 |
| Date Reported to FDA | 2016-02-11 |
| Date Reported to Mfgr | 2016-02-11 |
| Date Added to Maude | 2016-02-16 |
| 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 | AUTOSUTURE ENDO STITCH |
| Generic Name | SUTURE IMPLANTABLE |
| Product Code | MFJ |
| Date Received | 2016-02-16 |
| Catalog Number | 173016 |
| ID Number | 10 MM |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-16 |