MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for RETRACTOR 401-1610 manufactured by Atricure, Inc..
[140140738]
The estech retractor (cat# 401-1610; serial number (b)(4)) fell apart while being used for the procedure. A chest x-ray was taken at approximately 4:30 am and report received at 5:56 am; report was negative.
Patient Sequence No: 1, Text Type: D, B5
[141032654]
The estech retractor (cat# 401-1610 serial number (b)(4)) fell apart while being used for the procedure. A chest x-ray was taken at approximately 4:30 am and report received at 5:56 am; report was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8458941 |
| MDR Report Key | 8458941 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-26 |
| Report Date | 2019-03-27 |
| Date Reported to FDA | 2019-03-27 |
| Date Reported to Mfgr | 2019-03-28 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | RETRACTOR |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Product Code | DWS |
| Date Received | 2019-03-28 |
| Model Number | 401-1610 |
| Catalog Number | 401-1610 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |