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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE Back to Search Results
Model Number OLYMPUS CYF-VH, CYF-V2 AND CYF-5
Device Problems Failure To Adhere Or Bond (1031); Crack (1135); Degraded (1153)
Patient Problem No Information (3190)
Event Date 01/03/2018
Event Type  Malfunction  
Event Description

There is adhesive/glue that is applied on the distal and proximal end of the bending rubber that can cause concern of cracking or gaps in the adhesive that seals the devices distal cap to its distal tip. It has been identified that degradation is occurring with the adhesive on olympus cystoscopes. So far, degradation has occurred in at least 54 olympus cystoscopes, which have only been reprocessed approximately 22-23 times.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP
3500 corporate pkwy
center valley PA 18034
MDR Report Key7244555
MDR Text Key99126111
Report Number7244555
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 01/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberOLYMPUS CYF-VH, CYF-V2 AND 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 FDA01/19/2018
Device Age2 yr
Event Location No Information
Date Report TO Manufacturer01/19/2018
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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