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

Model Number CLK-4

Device Problem Optical Problem (3001)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

The customer reported the halogen light source fails to light up.The bulb was replaced; however, the issue persisted.The event occurred during preparation for use and there was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed by faulty power switch.In addition, front panel scratch, front socket air jointer worn-out, and power inlet crack were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.As a result of checking complaints in the past one year from the occurrence date of this complaint, the subject device had no repair history.Since the subject device was manufactured over 15 years ago, its record could not be checked.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to a failure of the power switch.As to the cause of the defect, it was not possible to further identify it because no further information could be obtained.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16308566
• MDR Text Key: 309162661
• Report Number: 3002808148-2023-01116
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024528
• UDI-Public: 04953170024528
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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: 01/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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