FDA Adverse Event
Other
Summary report: N
OLYMPUS
MDR report key: 184517
·
Received August 26, 1998
Report
- Report Number
- 9610773-1998-00020
- Event Type
- Other
- Date Received
- August 26, 1998
- Report Date
- August 18, 1998
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- FAJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
8/18/1998 THE SURGEON CONFIRMED THAT FOUR PT'S DEVELOPED URINARY TRACT INFECTIONS FOLLOWING CYSTOSCOPY PROCEDURES. THE FOUR PTS WERE HOSPITALIZED AND IT IS PRESUMED THAT TREATMENT WAS REQUIRED TO TREAT THE INFECTIONS. ADDITIONALLY, THE SURGEON REPORTED THAT ALL PT'S WHO HAVE RECENTLY UNDERGONE OR WILL BE HAVING CYSTOSCOPY PROCEDURES ARE OR WILL BE ROUTINELY TREATED WITH ANTIBIOTICS AS A PRECAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | CYSTOFIBERSCOPE | FAJ | OLYMPUS WINTER & IBE GMBH | CYF-3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |