MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-29 for FILSHIE CLIP SYSTEM * manufactured by Cooper Surgical.
[2260078]
Surgeon noted that the clip failed to fire. A second device was used without incident. It is unknown if the second device was the same or different lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2275040 |
| MDR Report Key | 2275040 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-09-29 |
| Date of Event | 2011-07-20 |
| Report Date | 2011-09-29 |
| Date Reported to FDA | 2011-09-29 |
| Date Added to Maude | 2011-10-04 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | FILSHIE CLIP SYSTEM |
| Generic Name | SURGICAL CONTRACEPTION SYSTEM |
| Product Code | HGB |
| Date Received | 2011-09-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 28002 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-29 |