MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-06 for THE FILSHIE CLIP AVM-851 * manufactured by Avalon Medical Corp.
[171011]
Filshie clip broke during firing from clip gun. Recovered piece and f/u done with x-ray. The surgeon using this reports similiar failures with this brand of sterilization clip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 280573 |
| MDR Report Key | 280573 |
| Date Received | 2000-06-06 |
| Date of Report | 2000-06-06 |
| Date of Event | 2000-03-17 |
| Date Facility Aware | 2000-03-21 |
| Report Date | 2000-06-06 |
| Date Added to Maude | 2000-06-07 |
| 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 | THE FILSHIE CLIP |
| Generic Name | * |
| Product Code | HOB |
| Date Received | 2000-06-06 |
| Model Number | AVM-851 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 0 DAY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 271529 |
| Manufacturer | AVALON MEDICAL CORP |
| Manufacturer Address | 372 HURRICANE LANE SUITE 201 WILLISTON VT 05495 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-06 |