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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 Problems Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated at sorc. As a result of the evaluation, the following was confirmed. -all leds on the front panel flashed due to the sticking of the mesh turret and filter turret. -the output socket rattled when the light guide was connected, due to the wear of the output socket. 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 medical systems corp. (omsc) was informed by the user that during the preparation for use, that all leds on the front panel were blinked. There was no report of patient injury associated with the event. Olympus then inspected the device at olympus service operation repair center (sorc) and found that the fuse box of the ac power inlet was burned.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. The mesh turret and filter turret may have malfunctioned due to deterioration due to normal use, because more than 12 years have passed since the device was delivered. The device is designed to notify by blinking the led on the front panel, when a turret malfunction (turret error) is detected. In addition, the burnt fuse box of the ac power inlet may have been caused by deterioration due to normal use. 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.
 
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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 Key12531283
MDR Text Key280958399
Report Number8010047-2021-12304
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 User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
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 Manufacturer09/03/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2009
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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