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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 Problems Erratic or Intermittent Display (1182); No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2021
Event Type  Malfunction  
Manufacturer Narrative

Olympus technical assistance center (tac) personnel attempted to troubleshoot the device with the customer but was unsuccessful. The customer noted that they would continue the procedure, and attempt further troubleshooting afterward. Follow up attempts with the user facility have been unsuccessful. At this time it does not appear the device will be returned. However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.

 
Event Description

It was reported, the biomedical engineer was attempting to troubleshoot the evis exera ii video system center as it was receiving poor quality and intermittent images. According to the initial reporter, the staff needed to hold the scope a specific way to maintain the image. Furthermore, when an image was present it would sometimes have a black line through it. There was no patient harm or consequence reported as a result of this 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 Key11414287
MDR Text Key234766296
Report Number8010047-2021-03321
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2021
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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