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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S40PRO
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The user returned the device to olympus because the front panel flashed. The device was evaluated at sorc. As a result of the evaluation, the following was confirmed. The front panel flashed due to a malfunction of the filter turret and mesh turret. The intensity mode could not be switched to the high intensity mode due to a failure of the high intensity detector of the light guide connector. From the following investigation results, the exact cause of the reported event could not be conclusively determined. Olympus medical systems corp. (omsc) reviewed the manufacturing history and confirmed that there were no manufacturing abnormalities or corrections. The device had no repair history. There was no report on the cause of the charring of the ac power inlet in the device evaluation results. Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus inspected the device at olympus service operation repair center (sorc) and found that the ac power inlet was burned. There was no report of patient injury associated with the event.
 
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Brand NameVISERA PRO XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
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 Key12981961
MDR Text Key286153887
Report Number8010047-2021-15971
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-S40PRO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2009
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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