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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 Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2017
Event Type  Malfunction  
Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp. For evaluation, but returned to olympus keymed (okm) in (b)(4). The subject device was sold on (b)(6) 2014, and the last serviced on june 13, 2017 for a leaking in universal cord. During the investigation by okm, it was confirmed that the subject device passed water leak test. It was also confirmed that the boot of the subject device was loose and the insertion tube could rotate. The boot was removed for further investigation and it was confirmed that the nut to fix the insertion tube to control section was loose and the insertion could rotate the failure of the previous repair could not be ruled out as a contributory factor of the reported event.

 
Event Description

Olympus was informed that when the user angulated the insertion tube of the subject device, the insertion tube rotated during a bladder inspection. The user removed the subject device from the patient and replaced with another device. The procedure was completed. There was no patient injury reported and the patient was reportedly fine.

 
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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
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6854339
MDR Text Key87227676
Report Number8010047-2017-01324
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2014
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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