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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 Display Difficult to Read (1181); No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) checked the subject device at the user facility and the coiled cord (bent terminal) of the video connector socket was found. The subject device was not returned to any of olympus locations. Based upon the information from the fse, omsc surmised that the reported phenomena were attributed to the contact failure between the processor and the endoscope by the bent terminal. Omsc considered that the bent terminal was attributed to the endoscope used in combination. Based upon the past similar case, omsc surmised that the bent terminal was attributed to the following mechanism. Chipped distal end of the endoscope connector was hooked on to the socket in the video connector of cv-180 when connecting. Hooked video connector was inserted further, ports in the video connector socket were pushed and bent. Olympus stated the appropriate handling of cv-180 and the counter measures against abnormalities in the instruction manual of cv-180.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user that during unspecified timing, it was found that the stripes were constantly displayed in the endoscope image or the endoscopic image was not displayed. The occurrence date of the event is unknown. There was no report of patient injury associated with the 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 Key12202395
MDR Text Key262660278
Report Number8010047-2021-09179
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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