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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Material Erosion (1214)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Upon discovering the incorrect reprocessing, the user facility immediately stopped using the scope and will send to olympus for repair. To date, the device has not been received. Facility will be receiving a new hld product. Additionally an in-service was scheduled for olympus personnel to properly instruct the user facility. However, the in-service was cancelled by the user facility due to covid-19. Olympus technical assistance center personnel will contact the customer in regards to rescheduling the in-service. At this time it does not appear the device will be returned. However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.
 
Event Description
During a device reduction and repair evaluation conducted by an olympus endoscopy support specialist, when evaluating the visera cysto-nephro videoscope the device appeared to have rust at the distal tip, the covering appeared to be deteriorating. It is possible the damage is due to incorrect reprocessing. The device was used on patients. The user facility is using resert for high level disinfection. The user facility reported that they had been using the scopes until they failed the leak test or produced no image. At this time, no patient harm or consequence reported as a result of this event.
 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
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 Key11368717
MDR Text Key244119835
Report Number8010047-2021-02907
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-V2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2017
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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