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

Model Number	CLH-250
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscopic support specialist (ess) visited the facility to address the "dim light." the ess was able to source a replacement bulb and replaced the bulb.The ess educated the staff on the process for future reference.The ess emailed the customer the manual for the light sourced to reference should the bulb require replacement again.This event is under investigation.A follow up will be submitted upon receiving additional information.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Actions are being taken to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
It was reported the customer was experiencing a "dim light" with the olympus halogen light source.No information regarding patient involvement was reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer's investigation.A review of the device history record (dhr) was conducted as part of the investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The root cause is likely the lamp reached the end of its service life.The service personnel replaced lamp for replacement in front of facility staff, taught when lamp change should occur in the future and a manual for exchange was sent to the clients.Olympus will continue to monitor the field performance of this device.

• 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
• MDR Report Key: 11211299
• Report Number: 8010047-2021-01700
• Device Sequence Number: 3556599
• Product Code: EOQ
• UDI-Device Identifier: 04953170024412
• UDI-Public: 04953170024412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1