FDA Adverse Event
Other
Summary report: N
OLYMPUS
MDR report key: 821917
·
Received February 22, 2007
Report
- Report Number
- 9610773-2007-00006
- Event Type
- Other
- Date Received
- February 22, 2007
- Report Date
- January 22, 2007
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- FAJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IN QUESTION WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THERE WAS NO FURTHER INFO OBTAINED FROM THE FACILITY DESPITE REPEATED ATTEMPTS. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) IS SCHEDULED TO VISIT THE ACCOUNT TO CONDUCT AN IN-SERVICE AND PROVIDE REPROCESSING TRAINING TO THE STAFF. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. IF ADD'L INFO IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL COMMENCE. THIS REPORT IS BEING FILED AS AN MDR IN AN EXCESS OF CAUTION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THREE PTS PRESENTED WITH PSEUDOMONAS INFECTIONS IN ONE WEEK. THERE WAS NO OTHER INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | CYSTOFIBERSCOPE | FAJ | OLYMPUS WINTER & IBE GMBH | CYF-4(OWI) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |