MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE

Model Number	CLH-250
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional 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.The lamp was not working due to a bad connection as the lamp socket had deteriorated.Additionally, the adhesive was found peeling, the side foot had a shortage and the output connector was worn.If additional information becomes available following the device evaluation, a supplemental report will be filed.
Event or Problem Description
The customer originally returned their olympus halogen light source has the lamp was not working even after it was replaced.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.During the device evaluation, it was confirmed that the lamp socket had deteriorated.This report is being submitted to capture the confirmed deteriorated lamp socket noted during the device evaluation.
Additional Manufacturer Narrative
This report is being submitted to capture additional information received from the initial reporter.Should further information be provided, another supplemental report will be submitted.
Event or Problem Description
Additional information was received noting that this occurred during a therapeutic procedure.The device was swapped out to complete the procedure with roughly a 10 minute delay, but no harm to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see corrections to b3, b5, e1 as this information was inadvertently left out of the prior medwatch report.Furthermore, please see the additional information to h6.The device is more than 15 years old and the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the lamp did not work due to a connection failure and deterioration of the lamp socket.The root cause of the event was unable to be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the initial reporter noting the olympus halogen light source did not work during a therapeutic sinus surgery.The device was not inspected prior to the procedure.There was no patient harm or consequence reported as a result of this event.

• Brand Name: HALOGEN LIGHT SOURCE
• Common Device Name: HALOGEN 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: 14427514
• Report Number: 8010047-2022-08370
• Device Sequence Number: 12369300
• Product Code: EOQ
• UDI-Device Identifier: 04953170024412
• UDI-Public: 04953170024412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: CLH-250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/15/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown