MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-21 for ENDO STITCH 170052 * manufactured by Covidien.
[6072649]
During the lap assisted hysterectomy, a needle from the covidien polysorb 0 es-09 broke during use. Half of the needle was retained within the endostitch device, the other half (tip of needle) was not found. The surgeon searched the wound and the operative site was irrigated and suctioned. The surgical staff searched the field and room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4891468 |
| MDR Report Key | 4891468 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-02-24 |
| Date of Event | 2015-02-17 |
| Report Date | 2015-02-24 |
| Date Reported to FDA | 2015-05-21 |
| Date Reported to Mfgr | 2015-07-06 |
| Date Added to Maude | 2015-07-06 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | MFJ |
| Date Received | 2015-05-21 |
| Model Number | 170052 |
| Catalog Number | * |
| Lot Number | B3A0402X |
| ID Number | * |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2015-05-21 |