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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 Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
During a nephrectomy, the subject device was used. The user selected standby mode of the subject device and put the light guide cable which was connected to the device on the surgical drape for about an hour and a half. After that, the surgical drape scorched. The brightness control of the device had been set to "manual". The intended procedure was completed with the subject device. There were no patient and facility staff injury reported.
 
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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 Key8730732
MDR Text Key149388384
Report Number8010047-2019-02286
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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