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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 Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned to olympus for evaluation. The user¿s complaint was not confirmed. The technical assistance center (tac) technician attempted to provided troubleshooting with the user over the phone. The technician made several suggestions for the user to try. The clv-180 lamp was burned out and the spare lamp was also burned out and the side door was loose. The user was going to try the suggested troubleshooting and call back if needed. No further information was reported. As the device was not returned for evaluation, we are unable to determine a root cause for the reported event. If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

 
Event Description

The user facility reported that the front panel of the cv-180 is blinking. The device had just been turned on. The front panel blinks intermittently. No errors, alarms, alerts, or warnings were received. The device was inspected, and no damage or abnormalities were observed. The connection is secure. The lamp was at 500 hours and needs to be replaced. There was no patient injury or harm reported. No additional information was provided.

 
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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 Key10508328
MDR Text Key224632727
Report Number8010047-2020-06347
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,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2020
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? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? No
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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