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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 subject device was returned to olympus service operation repair center (sorc). A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on (b)(6) 2021, it was found that the ac power inlet of the subject device was burnt. Other detailed information was not provided. 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 Key13234650
MDR Text Key289347494
Report Number8010047-2022-01298
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,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2022
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 Manufacturer12/10/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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