Device Problem
Microbial Contamination of Device (2303)
Patient Problem
No Patient Involvement (2645)
Event Type
Malfunction
Manufacturer Narrative
The scope was returned to the service center and is pending evaluation.
The cause of the reported event cannot be determine at this time.
As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.
To date, the ess visit has not been finalized.
Event Description
The service center was informed that on (b)(6) 2020 culture samples were taken from the scope after reprocessing.
The user facility reported that results received on (b)(6) 2020, show the scope cultured positive for positive for stenotrophomonas maltophilia.
The scope was cultured twice and both results were positive.
There was no patient involvement reported.