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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 Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to the service center for evaluation. The customer¿s complaint of ¿no color¿ was confirmed. The unit¿s printed circuit was found faulty causing no colors except black or white on the image. The unit will be repaired and returned to the customer.

 
Event Description

The service center was informed that during an unspecified procedure, there was no color on the image display. The connection was secure, other devices used with this processor were compatible, no resistance when inserting the connector to the port and the scope used was physically inserted into the port with no issues. The intended procedure was completed with a similar device. There were no other devices replaced during the procedure. The procedure was delayed one hour. There was no patient injury reported.

 
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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 Key10690674
MDR Text Key225375661
Report Number8010047-2020-07773
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 BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 10/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2020
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 Manufacturer09/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated By Manufacturer? Yes
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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