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

Model Number CLV-S45

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to local service department of olympus.Local service department checked the subject device and found that the ignition of the xenon lamp did not work.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the customer that during the preparation for use, xenon light worked unsteady and didn't start occasionally even after xenon lamp was replaced.There was no report of patient injury associated with the event.The event date was unknown.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.Since it has been about 7 years since the product was delivered, it was presumed that the igniter unit deteriorated and failed due to repeated use for a long period of time, causing the lamp to not light up.

• Brand Name: VISERA XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12381766
• MDR Text Key: 268685883
• Report Number: 8010047-2021-10911
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170275777
• UDI-Public: 04953170275777
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1