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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number OLYMPUS CYF-5
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
Event Type  Malfunction  
Event Description

Inspection of olympus cystoscopes with a borescope post reprocessing revealed black and red spots within the scopes. Brand new olympus scopes that were not yet used for patient care or reprocessed were also inspected and similar spots/markings were visible within these new scopes. Manufacturer response for cystoscopes, (brand not provided) (per site reporter). Olympus stated that they have received complaints from other device user facilities in the country regarding these same spots our facilities identified in the scopes. Olympus referred to these spots as "manufacturing details" but the manufacturer declined to put this in writing as a form of explanation. The manufacturer contends complaints correlate to the increase in the use of borescopes used by reprocessing facilities for scope inspections. It was also discussed with the manufacturer to send all scopes back to olympus for investigation; however, this was discouraged by the manufacturer since, as the manufacturer stated, the outcome will be the same with the markings still being present and visualized with a borescope.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
136 turnpike road
southborough MA 01772
MDR Report Key8183896
MDR Text Key131004225
Report Number8183896
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberOLYMPUS CYF-5
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2018
Event Location Hospital
Date Report TO Manufacturer12/20/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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