FDA Adverse Event
Other
Summary report: N
OLYMPUS
MDR report key: 276400
·
Received May 2, 2000
Report
- Report Number
- 8010047-2000-00026
- Event Type
- Other
- Date Received
- May 2, 2000
- Report Date
- April 3, 2000
- Manufacturer
- OLYMPUS OPTICAL CO. LTD.
- Product Code
- EOQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN OLYMPUS SALES REPRESENTATIVE WAS ADVISED BY A HOSP CLINICAL MANAGER THAT POSITIVE PT CULTURES WERE NOTED FOLLOWING BRONCHOSCOPY PROCEDURES. THE SALES REP RECALLED THAT THE CLINICAL MANAGER MENTIONED THAT THERE WERE 20 PTS AFFECTED; CULTURES WERE POSITIVE FOR VARIOUS MOLDS OR PSEUDOMONAS SPECIES. TO THE BEST OF THE CLINICAL MANAGER'S KNOWLEDGE, THERE WERE NO PT DEATHS BUT AT LEAST ONE PT WAS SERIOUSLY ILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | VIDEO BRONCHOSCOPE | EOQ | OLYMPUS OPTICAL CO. LTD. | BF-P240 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O |