MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-04 for FILSHIE CLIP APPLIER AVM-880, 5MM S1 APPLICATO * manufactured by Avalon Medical Corp.
[286133]
Filshie clip applier did not work properly during sterilization procedure. Upon examination of instrument, determined jaws of instrument did not close completely. The question is raised regarding when instrument failure occurred and how many pts whose clips may not have been applied properly and who may be unknowingly fertile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 427797 |
| MDR Report Key | 427797 |
| Date Received | 2002-11-04 |
| Date of Report | 2002-11-01 |
| Date of Event | 2002-10-28 |
| Date Facility Aware | 2002-10-28 |
| Report Date | 2002-11-01 |
| Date Added to Maude | 2002-11-18 |
| 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 |
| 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 APPLIER |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | HGB |
| Date Received | 2002-11-04 |
| Model Number | AVM-880, 5MM S1 APPLICATO |
| Catalog Number | * |
| Lot Number | * |
| ID Number | NA |
| Device Expiration Date | 2010-01-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 416809 |
| Manufacturer | AVALON MEDICAL CORP |
| Manufacturer Address | 185 ALLEN BROOK LANE WILLISTON VT 054959209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-11-04 |