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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 10/06/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to the service center for evaluation. The customer¿s complaint of ¿there is sections of the imaging blacking out intermittently and the screen black out is partial and complete" was not confirmed. The unit burned for over 2 hours with a test clv-180 and with our gif-h180, gif-q180 test scopes. The video image functioning normally. The unit passed all functional test and was found to have the current software version 4. 00 and nbi updated. The video connector was in normal condition.

 
Event Description

The service center was informed that during an unspecified procedure, the image would intermittently partially or completely go black. There were no error codes, alarms, or alert tones associated with this event. All of the settings were checked and found to be correct. All of the connections and cables were also checked and found to be secured. There wasn't any foreign objects such as detergent remnants, hard water residue, finger grease, dust or lint on the electrical contacts. There weren't any other devices involved in the event. No other devices were replaced during the procedure. There wasn't any delay in the procedure in which the subject device was used. The intended procedure was completed with a similar device. There was no patient injury. Additionally, the user facility reported that the device was inspected prior to the procedure and no abnormalities were noted. The cable was also inspected and no damage was noted.

 
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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 Key10764500
MDR Text Key225205699
Report Number8010047-2020-08351
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 01/15/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2020
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 Manufacturer10/20/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2020
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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