FDA Adverse Event
Injury
Summary report: N
ENDOGASTRIC SOLUTIONS ESOPHYX2
MDR report key: 3062661
·
Received March 25, 2013
Report
- Report Number
- 3062661
- Event Type
- Injury
- Date Received
- March 25, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ENDOGASTRIC SOLUTIONS
- Product Code
- ODE
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
PATIENT HERE FOR INCISIONLESS TRANSORAL FUNDOPLICATION. FIELD TRAINING MANAGER, HERE AS PRECEPTOR FOR DOCTOR FOR ENTIRE PROCEDURE. SCOPE AND DEVICE ADVANCED TO STOMACH WITH DIFFICULTY. BLEEDING NOTED AND UNABLE TO PERFORM PROCEDURE. SCOPE AND DEVICE REMOVED. SCOPE READVANCED AND ESOPHAGEAL PERFORATION NOTED. LEVAQUIN GIVEN AND FULLY COVERED. PATIENT REQUIRED THORACOTOMY AND REPAIR OF ESOPHAGEAL PERFORATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EGD WITH INCISIONLESS TRANSORAL FUNDOPLICATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121262 | ENDOGASTRIC SOLUTIONS ESOPHYX2 | ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX | ODE | ENDOGASTRIC SOLUTIONS | R2002 | 401334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |