FDA Adverse Event
Injury
Summary report: N
6VT-D PROBE
MDR report key: 4252931
·
Received November 12, 2014
Report
- Report Number
- 9610482-2014-00004
- Event Type
- Injury
- Date Received
- November 12, 2014
- Date of Event
- October 13, 2014
- Report Date
- October 14, 2014
- Manufacturer
- GE VINGMED ULTRASOUND AS
- Product Code
- IYO
- PMA / PMN Number
- K131514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. UNDER (B)(4) LAW, PATIENT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE DEVICE MANUFACTURE DATE IS UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS INJURED AFTER THE PHYSICIAN INTRODUCED THE PROBE INTO THE ESOPHAGUS. A CT SCAN CONFIRMED THAT THE PT SUSTAINED AN ESOPHAGUS PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729562 | 6VT-D PROBE | DIAGNOSTIC ULTRASONIC TRANSDUCER, IYO, ITX, IYN | IYO | GE VINGMED ULTRASOUND AS | KN100100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |