FDA Adverse Event
Injury
Summary report: N
VIVID-Q WITH 6TC-RS TRANSDUCER
MDR report key: 2476465
·
Received March 1, 2012
Report
- Report Number
- 9610482-2012-00001
- Event Type
- Injury
- Date Received
- March 1, 2012
- Report Date
- February 2, 2012
- Manufacturer
- GE VINGMED ULTRASOUND AS
- Product Code
- IYN
- PMA / PMN Number
- K102388
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INCIDENT DATE WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT SUFFERED A PERFORATION IN THE ESOPHAGUS AFTER A DIFFICULT PASSAGE OF A TRANSESOPHAGEAL (TEE) PROBE BY ANESTHETISTS WHEN UNDER GENERAL ANAESTHETIC FOR ATRIAL FIBRILLATION ABLATION. THE TEAR WAS >5 CM LONG AND REQUIRED URGENT ESOPHAGEAL SURGERY TO REPAIR. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIVID-Q WITH 6TC-RS TRANSDUCER | ULTRASONIC IMAGING SYSTEM | IYN | GE VINGMED ULTRASOUND AS | KN100104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |