MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-08 for FILSHIE CLIP REF. 9009-18 UNK manufactured by Coopersurgical, Inc..
[21958204]
During a laparoscopic tubal ligation, a filshie clip detached from the applier inside the abdomen. The doctor tried to remove the filshie clip through a trocar site per manufacturer's instructions. The filshie clip seemed to be stuck in the incision. X-rays were taken, c-arm radiology was used to locate clip, and clip was removed laparoscopically by surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 581350 |
| MDR Report Key | 581350 |
| Date Received | 2005-03-08 |
| Date of Report | 2005-02-18 |
| Date of Event | 2005-02-09 |
| Date Facility Aware | 2005-02-11 |
| Report Date | 2005-02-18 |
| Date Reported to FDA | 2005-03-07 |
| Date Reported to Mfgr | 2005-02-21 |
| Date Added to Maude | 2005-03-16 |
| 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 |
| 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 |
| Generic Name | FILSHIE CLIP |
| Product Code | HGB |
| Date Received | 2005-03-08 |
| Model Number | REF. 9009-18 |
| Catalog Number | UNK |
| Lot Number | A1707802 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 571198 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * SHELTON CT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-08 |