MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for ENDO STITCH 173016 manufactured by Covidien Lp.
[184279242]
The endo stitch was used once without issues. After reloading suture and giving it back to the surgeon it stopped working. The needle wouldn't toggle back and forth and wouldn't stay closed. Manufacturer response for endo stitch, endo stitch (per site reporter). No communication at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859484 |
| MDR Report Key | 9859484 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-05 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ENDO STITCH |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2019-12-17 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J9G2840EY |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |