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

Model Number CLH-SC

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation found that the device using halogen light powered up for over 12 hours over 2 days.It was recommended to replace the non-olympus halogen lamp and missing spare lamp made by olympus to prevent problems from happening again.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device evaluation, that the light source exhibited that the ceramic lamp socket unit was too loose when connected to halogen lamp.There were no reports of patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over thirteen (13) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause for ''lamp keeps burning up'' could not be determined.However, it is likely that the reported issue occurred due to a loose ceramic lamp socket unit.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.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: 18881929
• MDR Text Key: 337846372
• Report Number: 3002808148-2024-02296
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024481
• UDI-Public: 04953170024481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: Other
• Device Model Number: CLH-SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2011
• 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