FDA Adverse Event
Injury
Summary report: N
ESOPHYX2 -05
MDR report key: 2473240
·
Received February 29, 2012
Report
- Report Number
- 3005473391-2012-00057
- Event Type
- Injury
- Date Received
- February 29, 2012
- Date of Event
- February 20, 2012
- Report Date
- February 20, 2012
- Manufacturer
- ENDOGASTRIC SOLUTIONS, INC
- Product Code
- ODE
- PMA / PMN Number
- K092400
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO ALLEGATION OF PRODUCT MALFUNCTION AND THE DEVICE WAS DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR AN EVALUATION.
Description of Event or Problem · 1
FOLLOWING A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, A TEAR IN THE DISTAL ESOPHAGUS JUST PROXIMAL TO THE VALVE WAS SEEN POST-OPERATION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). TWO CLIPS WERE PLACED TO STOP THE BLEEDING. PATIENT IS REPORTEDLY DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESOPHYX2 -05 | ODE | ODE | ENDOGASTRIC SOLUTIONS, INC | R2000 | 400814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |