FDA Adverse Event
Injury
Summary report: N
UNKNOWN ENDO GIA SULU
MDR report key: 2142858
·
Received June 21, 2011
Report
- Report Number
- 1219930-2011-00522
- Event Type
- Injury
- Date Received
- June 21, 2011
- Report Date
- May 24, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE STUDY: THE DEVICE WAS USED TO DIVIDE THE DUCT. THE GALLBLADDER WAS DISSECTED FROM THE LIVER BED WITH DIATHERMY. ON THE FIRST POSTOPERATIVE DAY, THE PT DEVELOPED SIGNS OF PERITONITIS. SHE UNDERWENT EMERGENCY REPEAT LAPAROSCOPY AND WAS FOUND TO HAVE BILE THROUGHOUT THE PERITONEAL CAVITY. AFTER WASHOUT OF THE BILE, THE CYSTIC STUMP WAS EXAMINED. THE STAPLE LINE WAS INTACT, BUT BILE WAS TRICKLING THROUGH. THE CYSTIC STUMP WAS REINFORCED WITH INTERRUPTED ABSORBABLE SUTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ENDO GIA SULU | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| O| R |