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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-5R
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2020
Event Type  Malfunction  
Manufacturer Narrative

As part of our investigation, an endoscopy support specialist(ess) was dispatched to the user facility on september 02, 2020 to provide a repair reduction and education to the facility¿s staff. The ess reported that during an onsite customer visit the facility¿s reprocessing practices were discussed and the customer reported that leak testing is not performed as there is no leak tester onsite. Further discussion, found that the scope were stored in hangers at the end of the counter and not in a vented cabinet. The ess observed two tubes of disinfectant which are used to disinfect the insertion tube and not the scope in its entirety. The ess also, reported that the rinsing and drying of the scope post disinfection is not in accordance with manufacturer¿s recommendation. The device was not returned to the service center for evaluation. A review of the instrument history was performed and found no service/repair record since the date of purchase on may 13, 2014.

 
Event Description

The service center was informed that the user facility is improperly reprocessing two of its cystoscopes. The scopes were found to have multiple broken fibers and stains on the lens. There was no patient infection reported. This is 1 of 2 reports.

 
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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 Key10590093
MDR Text Key224665439
Report Number8010047-2020-06893
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,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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