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

Model Number CLV-S40PRO

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at sorc.As a result of the evaluation, the following was confirmed.-all leds on the front panel flashed due to the sticking of the mesh turret and filter turret.-the output socket rattled when the light guide was connected, due to the wear of the output socket.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, that all leds on the front panel were blinked.There was no report of patient injury associated with the event.Olympus then inspected the device at olympus service operation repair center (sorc) and found that the fuse box of the ac power inlet was burned.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The mesh turret and filter turret may have malfunctioned due to deterioration due to normal use, because more than 12 years have passed since the device was delivered.The device is designed to notify by blinking the led on the front panel, when a turret malfunction (turret error) is detected.In addition, the burnt fuse box of the ac power inlet may have been caused by deterioration due to normal use.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.

Manufacturer Narrative

This supplemental report is being submitted to correct g3 "date received by manufacturer" in the mfr report #8010047-2021-12304.Olympus re-evaluated the event reported in the initial report and determined that the event reported by the user, that all leds on the front panel were blinked, is not a mdr reportable malfunction.Therefore, the correct g3 "date received by manufacturer" in the initial report is september 8, 2021 when the mdr reportable event that the fuse box of the ac power inlet was burned was found.If additional information becomes available, this report will be supplemented.

• Brand Name: VISERA PRO 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12531283
• MDR Text Key: 280958399
• Report Number: 8010047-2021-12304
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1