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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 Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2015
Event Type  Malfunction  
Manufacturer Narrative

This device referenced in this report has not been returned to olympus keymed for evaluation. A leakage test was carried out and positive leak was confirmed from the biopsy channel. Further investigation found the leaking area to be located at the connection between the biopsy channel and the channel mount. Fluid ingress and severe corrosion were present internally within the control section. The biopsy channel was confirmed to be damaged and leaking and has resulted in fluid entry within the instrument control section. The fluid ingress has subsequently caused severe corrosion to the biopsy port and surrounding areas. Based on the above observations, the substance found to be leaking from the instrument channel is attributed to the fluid that has entered the instrument through the leak, has subsequently discolored through corrosion and mixing with internal lubricants, and then has leaked back out of the instrument. The manufacturing history was reviewed, with no irregularities related to this problem noted. The instrument was sold (b)(6) 2012 and has no repair history with olympus service.

 
Event Description

Olympus medical systems corp. (omsc) was informed that the subject device showed signs of leaking brown fluid in the storage cabinet after reprocessing. There was no patient harm reported.

 
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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 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key5122849
MDR Text Key27617486
Report Number8010047-2015-00918
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK#:K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility,FOREIGN,HEALTH PROFESSIONA
Reporter Occupation
Type of Report Initial
Report Date 09/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2015
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Device Catalogue NumberCYF-V2
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2012
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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