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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 Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device was evaluated. Evaluation determined that the device pip bnc cable was worn out which caused the intermittent image. The pc board stop button function was found to be nonfunctional. Minor corrosion was found on the device chassis and video connector was found to be in normal condition. The identified parts were replaced and repaired, software was upgraded. Once completed, the device was tested and passed all required functional testing and specifications. As stated on the ifu and as a preventive measure, the user manual states : in case of video system center failure or malfunction, always keep another video system center in the room ready for use.

 
Event Description

It was reported that during preparation for use , the lightsource device had an intermittent power issue. According to the reporter the picture in the picture port of the dnc connector worked intermittently. The device was determined to have a damage on the pc card and was not working. The intended procedure was completed using a similar device. There was no patient harm or injury reported due to the event.

 
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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 Key10072374
MDR Text Key207815653
Report Number8010047-2020-02793
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2020
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 Manufacturer04/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/10/2010
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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