MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus for evaluation.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the subject device was not returned to omsc, the exact cause was unknown.Omsc surmised that the reported phenomenon occurred since the lamp has deteriorated and burned out due to repeated use for a long period of time.

Event Description

Olympus medical systems corp.(omsc) was informed that the local field service engineer checked the subject device at the facility and found that the examination lamp of the subject device was exhausted.The local field service engineer replaced the examination lamp with a new one.The event date was unknown.Other detailed information was not provided.There was no report of patient injury associated with the event.

• Brand Name: VISERA 4K UHD 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: 12678274
• MDR Text Key: 280941322
• Report Number: 8010047-2021-13538
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/22/2021

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-S400
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2021
• Initial Date FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1