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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to the service center for evaluation. The unit was burn in tested for 4+ hours with a test clv-180 light source. The customer¿s complaint was not confirmed. Unit passed all functional tests. All video output signals and video connector tested normal. The unit is equipped with ver. 4. 00 software. The customer¿s complaint was not confirmed. The unit was returned to the customer.

 
Event Description

The service center was informed that during preparation for use, there was no image observed. The customer believes that the device¿s paddle connection is defective. It was reported that if the cable was moved around, the scope image would sometimes display; however, as soon as the cord was released, the image would disappear again. Two different cables were tested, one being a brand new cable, but the image still would not display. There was no report of patient involvement.

 
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Brand NameEVIS EXERA II VIDEO SYSTEM CENTER
Type of DeviceVIDEO SYSTEM CENTER
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 Key10208935
MDR Text Key224635492
Report Number8010047-2020-03728
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCV-180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2007
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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