FDA Adverse Event
Injury
Summary report: N
FILSHIE CLIP
MDR report key: 2160802
·
Received July 7, 2011
Report
- Report Number
- 1216677-2011-00011
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 23, 2011
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- KNH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONE SAMPLE CLIP WAS RETURNED IN A BIOHAZARD PLASTIC BAG. THERE IS NO SIGN OF OR ANY INDICATION THAT THE CLIP WAS ACTIVATED. IT IS THEREFORE HIGHLY UNLIKELY THAT THE CLIP ITSELF WAS THE CAUSE FOR THE BLEEDING INDICATED. A REVIEW OF OUR COMPLAINT DATABASE REVEALS NO OTHER COMPLAINTS AGAINST AVM-851 LOT# 26959. (B)(4).
Description of Event or Problem · 1
SURGEON WAS PERFORMING A LAPAROSCOPIC PROCEDURE AND THE CLIP WOULD NOT CLOSE AND TORE THE FALLOPIAN TUBE THAT CAUSED BLEEDING AND THEN DOCTOR HAD TO CAUTERIZE TO STOP THE BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILSHIE CLIP | NONE | KNH | COOPERSURGICAL, INC. | 26959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |