FDA Adverse Event
Injury
Summary report: N
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT
MDR report key: 3223138
·
Received June 26, 2013
Report
- Report Number
- 3223138
- Event Type
- Injury
- Date Received
- June 26, 2013
- Report Date
- June 26, 2013
- Manufacturer
- W. L. GORE & ASSOCIATES, INC
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
Narratives
Description of Event or Problem · 1
PATIENT APPROXIMATELY 3 DAYS POST VERTICAL SLEEVE GASTRECTOMY WITH ABDOMINAL PAIN, NAUSEA, VOMITING, TACHYCARDIA. CT CONSISTENT WITH LEAK OF HER STAPLE LINE. INITIAL SURGERY WAS UNEVENTFUL; NO LEAK DETECTED AT THAT TIME. PATIENT RETURNED TO OR FOR SURGICAL REPAIR.======================MANUFACTURER RESPONSE FOR STAPLE LINE REINFORCEMENT, SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT (PER SITE REPORTER).======================HE REPORTED IT TO THE FDA.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOTIC ASSISTED LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY. ROBOT ASSISTED LAPAROSCOPIC HIATAL HERNIA REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289684 | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC | 12BSGEC60A | 314721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| L| R | DAVINCI ROBOT WAS ASSISTING |