FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS
MDR report key: 1032387
·
Received April 16, 2008
Report
- Report Number
- 8010047-2008-00065
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Report Date
- March 17, 2008
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Product Code
- FDS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DID NOT DUPLICATE THE USER'S REPORT OF A REDUCED OR UNCLEAR ULTRASOUND IMAGE. THE ULTRASOUND IMAGE WAS DETERMINED TO BE WITHIN SPECIFICATION, HOWEVER THE VIDEO IMAGE WAS NOTED TO FOG DUE TO MOISTURE INSIDE THE OBJECTIVE LENS. THE SOURCE OF THE MOISTURE COULD NOT BE DETERMINED AS THE UNIT PASSED LEAK TESTING. THIS REPORT IS BEING FILED AS AN MDR, IN AN ABUNDANCE OF CAUTION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC FINE NEEDLE ASPIRATION, THE ULTRASOUND IMAGE WAS OBSERVED TO BE REDUCED AND UNCLEAR. THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | ULTRASONIC GASTROVIDEOSCOPE | FDS | OLYMPUS MEDICAL SYSTEMS CORPORATION | GF-UC140P-I | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |