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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 Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to omsc for evaluation. Omsc inspected the device and confirmed the following: the high intensity scope detection sensor of the output socket failed due to deformation of metal parts and wear of the light guide insertion part due to repeated connections. The mesh turret stuck and malfunction occurred. There was no abnormality in the appearance of the lamp. When the light intensity of the device was measured using the olympus actinometer osb-2, it was confirmed that the light intensity was within the standard value. The lid of the device was opened and the inside was checked, and it was confirmed that there was no abnormality. It was confirmed that there was no abnormality after continuous operation for a long time. The exact cause of the reported event could not be conclusively determined. However, the reported event that he ac power inlet was scorched may have been caused by aging due to long-term repeated use, because more than 12 years have passed since the device was manufactured. 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.
 
Event Description
Olympus medical systems corp. (omsc) inspected the device and found that the ac power inlet of the device was scorched. 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 Key11869114
MDR Text Key252154848
Report Number8010047-2021-06648
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
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
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 Manufacturer03/15/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2008
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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