FDA Adverse Event
Injury
Summary report: N
ENDO CLIP 5MM CLIP APPLIER
MDR report key: 1023293
·
Received April 1, 2008
Report
- Report Number
- 1219930-2008-00228
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- December 26, 2007
- Report Date
- December 27, 2007
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDO
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 04/01/2008.
Description of Event or Problem · 1
PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THREE CLIPS WERE FIRED BUT THEY DID NOT FORM PROPERLY ON TISSUE. WHILE REMOVING ONE OF THEM FROM THE CAVITY, THE OTHER TWO CLIPS DISENGAGED AND FELL INTO THE CAVITY. THE CLIPS COULD NOT BE FOUND DURING THE PROCEDURE, BUT WERE CONFIRMED BY X-RAY THAT THEY WERE STILL INSIDE THE BODY. THE PATIENT STATUS WAS REPORTED AS FINE AND WAS RELEASED FROM T HE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP 5MM CLIP APPLIER | CLIP APPLIER | GDO | NORTH HAVEN - USS | N3K452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |