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

Model Number CLK-4

Device Problem Loss of Power (1475)

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing, and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that during a diagnostic bronchoscopy procedure, the halogen light source did not have any power.The intended procedure was postponed and completed later with a similar device.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Additionally, the repair center found dust in the unit, two washers at the chassis were missing, as well as multiple scratches / cosmetic damage to the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the procedure was postponed due to the device failure that the customer experienced.However, the root cause of the power not turning on was unable to be identified, as the event was unable to be reproduced during the device evaluation.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer (see updated sections b5).

Event Description

Additional information was provided by the customer.The patient was asked to visit another hospital; the procedure was postponed, but no more information is known as the patient was shifted to another hospital.The patient was not under general anesthesia until he remained in the hospital before being asked to visit another hospital.

• 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: 16673471
• MDR Text Key: 313020716
• Report Number: 3002808148-2023-03276
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 05/22/2023
• Supplement Dates FDA Received: 05/17/2023; 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• 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