FDA Adverse Event
Injury
Summary report: N
ESOPHY X2 -05
MDR report key: 1812132
·
Received July 30, 2010
Report
- Report Number
- 3005473391-2010-00014
- Event Type
- Injury
- Date Received
- July 30, 2010
- Date of Event
- July 2, 2010
- Report Date
- July 2, 2010
- Manufacturer
- REDMOND
- Product Code
- ODE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DID NOT ALLEGE ANY DEVICE MALFUNCTION OR PROCEDURAL ISSUES.
Description of Event or Problem · 1
DURING DEVICE EXTRACTION AFTER COMPLETING THE PROCEDURE, THE PHYSICIAN NOTICED A POSSIBLE ESOPHAGEAL TEAR. AFTER INSERTING THE ENDOSCOPE FOR THE NORMAL POST-PROCEDURE CHECK, A SMALL TEAR WAS CONFIRMED, APPROX 3 CM ABOVE THE HIGHEST FASTENER PLACEMENT. NO AIR WAS SEEN IN THE CHEST X-RAY, NO CONTRAST SEEN IN THE FOLLOW-UP CAT SCAN, AND THERE WAS NO EVIDENCE OF EXTRAVASATION. THE PT WAS KEPT BEYOND THE NORMAL PROCEDURAL HOSPITAL STAY FOR AN ADDITIONAL THREE DAYS FOR OBSERVATION. THE PT RECOVERED NORMALLY AND WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESOPHY X2 -05 | ODE | REDMOND | R2000 | 400655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R |