FDA Adverse Event
Summary report: N
OLYMPUS
MDR report key: 1905633
·
Received October 29, 2010
Report
- Report Number
- 1905633
- Date Received
- October 29, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 28, 2010
- Manufacturer
- OLYMPUS AMERICA, INC.
- Product Code
- HRX
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SCOPE IMAGE FOGGED AND WAS UNABLE TO BE CLEARED. THE DEVICE WAS REPLACED WITH ANOTHER SCOPE, WHICH EVENTUALLY FOGGED AS WELL. THE PHYSICIAN THEN CONVERTED THE PROCEDURE TO AN OPEN SHOULDER PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SCOPE HAD BEEN SENT TO A THIRD PARTY VENDOR FOR CLEANING. THIS ISSUE MAY HAVE SOMETHING TO DO WITH THAT PART OF THE PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | ARTHROSCOPE | HRX | OLYMPUS AMERICA, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |