FDA Adverse Event
Injury
Summary report: N
ESOPHYX2 -05
MDR report key: 2556656
·
Received May 2, 2012
Report
- Report Number
- 3005473391-2012-00061
- Event Type
- Injury
- Date Received
- May 2, 2012
- Date of Event
- April 13, 2012
- Report Date
- April 16, 2012
- Manufacturer
- ENDOGASTRIC SOLUTIONS, INC
- Product Code
- ODE
- PMA / PMN Number
- K092400
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 EVALUATION.
Description of Event or Problem · 1
DURING A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, POOR INSUFFLATION LEAD TO POOR VISIBILITY. THE SURGEON PLACED A FASTENER HIGHER THAN THE GASTROESOPHAGEAL JUNCTION AND IT PULLED THROUGH THE ESOPHAGUS CAUSING A PERFORATION. A SWALLOW TEST WAS PERFORMED POST OPERATION AND THE SURGEON WAS NOT HAPPY WITH THE RESULTS AND DECIDED TO OPERATE TO REPAIR AND PLACE CHEST TUBES. THE PATIENT WAS ADMITTED INTO ICU AND STAYED THERE FOR A WEEK. ANOTHER SWALLOW TEST WAS PERFORMED AND EVERYTHING LOOKED OKAY. THE PATIENT HAS SINCE BEEN SENT HOME AND IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESOPHYX2 -05 | ODE | ODE | ENDOGASTRIC SOLUTIONS, INC | R2000 | 400718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |