FDA Adverse Event
Injury
Summary report: N
ENDO CLIP 5MM CLIP APPLIER
MDR report key: 1153276
·
Received September 8, 2008
Report
- Report Number
- 1219930-2008-00670
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 20, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDO
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/08/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE CLIP DID NOT CLOSE WHEN APPLIED. THERE WAS TISSUE DAMAGE AND BLEEDING FROM THE ARTERY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INCIDENT DETAILS WERE DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP 5MM CLIP APPLIER | DISPOSABLE SURGICAL CLIP APPLIER | GDO | NORTH HAVEN - USS | N8D98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |