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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 facility requested an inspection of the device because the control panel flashed during the procedure. The device was evaluated at sorc. As a result of the evaluation, the following was confirmed. -the phenomenon reported by the user was not reproduced. -narrow-band imaging was defective due to turret sticking. -there was rattling when connecting the light guide due to wear of the output socket. -the mesh turret was stuck. -there was a dent on the switch on the front panel. The exact cause of the reported event could not be conclusively determined at this time. 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 fuse box of the ac power inlet was burnt. 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 Key12595557
MDR Text Key281531125
Report Number8010047-2021-12887
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,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
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 Manufacturer09/09/2021
Was the Report Sent to FDA? No
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2008
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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