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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problems Crack (1135); Fluid Leak (1250); Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The report is being submitted to provide the customer's report of the event as well as investigation findings. The device referenced in this report has been evaluated by olympus. Physical evaluation of the complaint device reveals: the device failed the leak test due to detached instrument channel port. The rubber glue is cracked and there is peeling cement on the lens. The lens has minor scratches. The insertion tube has a minor dent. The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped. The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: chapter 9 storage 3. 4 inspection of accessories inspection of the forceps/irrigation plug ¿ if any irregularity is observed on the biopsy valve of the forceps/irrigation plug, replace it with a new biopsy valve. A damaged or deformed biopsy valve can reduce the efficacy of the air/water feeding function and may cause fluid to leak or spray from the forceps port of the forceps/irrigation plug. Conclusion: the definitive cause of the user's experience could not be determined. Based on the available information, the following are presumed to be possible causes: the t-tube mounting cap (instrument channel port) was subjected to excessive external force when attaching or detaching the t-tube (forceps/irrigation plug), which may have resulted in damage (loosening or deformation. In addition, 8 years and 4 months had passed since manufacturing of the device and it may have been affected by aging/use degradation.
 
Event Description
It was reported during reprocessing of a cysto-nephro videoscope, the biopsy port pulled out. There was no patient contact/impact related to this occurrence.
 
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Brand NameCYSTO-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 Key11423855
MDR Text Key244559468
Report Number8010047-2021-03376
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2012
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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