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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 device has not been returned to omsc but was returned to olympus medical systems (b)(4) private limited (b)(4) for evaluation. (b)(4) inspected the device and confirmed the following: the output socket was deformed because the adapter of the light guide connector was stuck inside. There were no cracks in the output socket. There was no abnormality in the endoscopic image, and the image was displayed with the connected endoscope. The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc. However, the user may have applied excessive force when connecting the endoscope to the device, causing the light guide of the endoscope to break and remain inside the output socket of the device. Omsc concluded that the output socket was also deformed for the same reason. The instruction manual provides preventive measures against the reported failure mode. 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) was informed by the user that it was found that the adapter for the light guide connector was stuck inside the output socket of the device. 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 Key11817622
MDR Text Key250395885
Report Number8010047-2021-06240
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/13/2021
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-S40PRO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2011
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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