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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

The scope was returned to the service center however the evaluation is in progress. A review of the service history of the scope indicates the scope was purchased on (b)(6) 2019 with no repair history. In response to the user facility's request, the endoscopy support specialist (ess) visited the user facility to perform an in-service on leak testing and reprocessing. The ess discovered there was no leak tester on site. The facility has never purchased a leak tester for reprocessing. The ess informed the staff the importance of leak testing and it is a required step per manufacturer guidelines. Additionally, the ess performed an infection control in-service for the staff and recommended that the customer refer to the olympus instruction manual and ontrack forms for proper reprocessing instruction. The ess reviewed all proper reprocessing steps including and specifically focusing on leak testing with the staff. The user facility has requested to purchase a leak tester. The investigation is ongoing. If additional information becomes available, this report will be supplemented accordingly.

 
Event Description

The service center was made aware that two patients cultured positive for salmonella. This is for report 2 of 2.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9238852
MDR Text Key177841114
Report Number8010047-2019-03713
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 02/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/25/2019 Patient Sequence Number: 1
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