MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-29 for FILSHIE CLIP APPLIER S55950 manufactured by Avalon Medical Corp.
[630565]
During tubal sterilization, the filshie clip applier failed to fire completely. After removal of the applier form the abdominal cavity, the device was visually inspected and found to have separated at one of the pressed steams. Procedure-tubal sterilization- was accomplished via on alternative method, i. E. , kleppinger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002133 |
| MDR Report Key | 859337 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-29 |
| Date of Event | 2007-05-18 |
| Date Added to Maude | 2007-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| 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 | 2007-05-29 |
| Returned To Mfg | 2007-05-23 |
| Catalog Number | S55950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 845166 |
| Manufacturer | AVALON MEDICAL CORP |
| Manufacturer Address | 185 ALLEN BROOK LANE WILISTON VT 054952070 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-29 |