FDA Adverse Event
Injury
Summary report: N
ESOPHYX2 - LINK DESIGN - SHORT
MDR report key: 4225537
·
Received November 4, 2014
Report
- Report Number
- 3005473391-2014-00090
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- September 5, 2014
- Report Date
- October 6, 2014
- Manufacturer
- ENDOGASTRIC SOLUTIONS, INC
- Product Code
- ODE
- PMA / PMN Number
- K092400
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PHYSICIAN ADVANCED THE ENDOSCOPE AND WAS VISUALIZING THE INSERTION. WHEN THE SCOPE WAS RETRACTED TO RELEASE IT FROM THE DISTAL END OF THE DEVICE, IT WAS NOTICED THE RETAINER BAND WAS BROKEN. THE DEVICE WAS REMOVED AND THE ESOPHAGUS EXAMINED WITH THE ENDOSCOPE. AN ESOPHAGEAL LACERATION WAS OBSERVED. THE PHYSICIAN DECIDED TO OPEN THE PATIENT AND REPAIR THE DAMAGE BECAUSE OF THE LACERATION SIZE. FOLLOW-UP THREE DAYS LATER WITH THE PHYSICIAN FOUND THE PATIENT DOING WELL. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706042 | ESOPHYX2 - LINK DESIGN - SHORT | ODE | ODE | ENDOGASTRIC SOLUTIONS, INC | R2002 | 401628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| R |