FDA Adverse Event
Other
Summary report: N
TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER
MDR report key: 2001041
·
Received February 11, 2011
Report
- Report Number
- 1218950-2011-00377
- Event Type
- Other
- Date Received
- February 11, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 7, 2011
- Manufacturer
- PHILIPS ULTRASOUND
- Product Code
- IYN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE WHETHER THE TEE PROBE OR ULTRASOUND SYSTEM MAY HAVE CAUSED THE INJURY. THE INITIAL EVALUATION OF THE ULTRASOUND SYSTEM BY PHILIPS ENGINEERING FOUND NO INDICATION OF A DEVICE FAILURE. THE TRANSDUCER HAS BEEN REMOVED FROM SERVICE AND IS BEING RETURNED TO THE FACTORY FOR EVALUATION.
Description of Event or Problem · 1
PHILIPS HEALTHCARE RECEIVED AN ADVERSE EVENT REPORT FOLLOWING A TEE EXAMINATION WITH THE PHILIPS IE33 ULTRASOUND SYSTEM. THE EVENT INVOLVED A CRITICALLY ILL (B)(6) FEMALE AND WAS DESCRIBED AS FOLLOWS: "FOLLOWING THE TEE EXAM, A BLOOD CLOT FORMED IN THE PT'S ESOPHAGUS WHICH LEAD TO A PERFORATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER | CX7-2T | IYN | PHILIPS ULTRASOUND | 453561265641 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |