MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for ENDO STITCH 173016 manufactured by Covidien.
[181159840]
Surgeon stated that the device would not lock and toggle would not stick. A new handpiece was opened to complete procedure. Manufacturer response for suturing device, covidien endo-stitch (per site reporter). After multiple reminder phone calls, manufacturer provided rga# and product return packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763942 |
| MDR Report Key | 9763942 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-08 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J9F1512EY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-27 |