FDA Adverse Event
Injury
Summary report: N
ENDO CLIP MED/LRG 10MM PISTOL GRIP APPL
MDR report key: 1454866
·
Received August 21, 2009
Report
- Report Number
- 1219930-2009-00559
- Event Type
- Injury
- Date Received
- August 21, 2009
- Date of Event
- July 20, 2009
- Report Date
- July 31, 2009
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT SENT: 08/21/2009.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE, ACCORDING TO THE REPORTER: POST OPERATION IN 2009, SURGERY WAS PERFORMED TO CORRECT THE PROBLEM, WHICH WAS REPORTED AS A BOWEL LEAK AT THE LEVEL OF THE SEPTIC DUCT. A BILIARY STENT WAS PLACED. PATIENT WILL HAVE TO RETURN BACK TO THE HOSPITAL IN 4 WEEKS TO HAVE THE PROCEDURE DONE AGAIN HOPING NO LEAKS WILL BE NOTICED. NO OTHER INFORMATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP MED/LRG 10MM PISTOL GRIP APPL | DISPOSABLE PISTOL GRIP APPLIER | GDO | NORTH HAVEN - USS | N8K347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |