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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S40
Device Problems Break (1069); Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to omsc but was returned to olympus (b)(4) for evaluation. (b)(4) inspected the device and confirmed the following; the emergency lamp indicator flashed due to the transformer failure. This device has not been repaired in the past year. 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, the examination lamp of the device was broken and the emergency lamp indicator was blinked. The patient was not yet anesthetized when the reported malfunction occurred. The device was used in combination with the video system center. The user replaced the device to another device and completed the intended procedure, hysteroscopy. There was no report of patient injury associated with the event.
 
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Brand NameVISERA 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 Key11817579
MDR Text Key251404864
Report Number8010047-2021-06241
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K954451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-S40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2010
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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