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

Model Number CLV-S40

Device Problems Break (1069); Erratic or Intermittent Display (1182)

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

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(4) for evaluation.(b)(4) inspected the device and confirmed the following; the emergency lamp indicator flashed due to the transformer failure.This device has not been repaired in the past year.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the preparation for use, the examination lamp of the device was broken and the emergency lamp indicator was blinked.The patient was not yet anesthetized when the reported malfunction occurred.The device was used in combination with the video system center.The user replaced the device to another device and completed the intended procedure, hysteroscopy.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus china sales & marketing (ocsm) for evaluation.Ocsm inspected the device but could not confirm any damage to the examination lamp of the device.Therefore, omsc conducted an investigation only on the reported blinking of the emergency lamp indicator.More than 10 years have passed since the device was manufactured and delivered, and the emergency light display may have blinked because the power supply unit (transformer 4u) failed due to wear.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.

• 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: 11817579
• MDR Text Key: 251404864
• Report Number: 8010047-2021-06241
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K954451
• 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: 06/08/2021

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: Health Professional
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1