MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HALOGEN LIGHT SOURCE

Model Number CLK-4

Device Problem Power Problem (3010)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.A faulty thermal fuse was discovered and causing both the lamp failure as well as the fan failure.Additionally, there was a dent noted on the frame and the heat stopper will require replacing.Scratches were found on the top cover, the rear panel, the front panel, and the chassis.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer reported that his olympus halogen light source¿s was experiencing power issues during a routine maintenance check.According to the initial reporter, the green light of the power switch was present, but neither the lamp nor the fan were functioning.There was not patient involvement during this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to a faulty thermal fuse.Olympus will continue to monitor field performance for this device.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: HALOGEN LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15249103
• MDR Text Key: 305517679
• Report Number: 3002808148-2022-01150
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024511
• UDI-Public: 04953170024511
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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: CLK-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1