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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 No Display/Image (1183); Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed from the user facility that during the preparation for a diagnostic gastroscopy procedure using the subject device, it was found that the endoscopic image of the subject device was not displayed on the monitor. There was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus europa se & co. Kg (oekg). Oekg checked the subject device and found that the reported phenomenon was duplicated, and also found that the front panel of the subject device was broken and the power of the subject device was not turned on. The exact cause has been under investigation. Therefore, the exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
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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
MDR Report Key12381349
MDR Text Key280775606
Report Number8010047-2021-10897
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCV-180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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