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

Model Number CLH-SC

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The user reported that the lamp was replaced and is now in working conditions.No other issues have been reported.The investigation has been completed.We are unable to perform a device history record review as the serial number was not provided.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the error occurred because the user did not recognize that lamp was blown or did not know how to replace lamp.If additional information is obtained, a supplemental report will be filed.

Event Description

A user facility reported a light source powers on but no light is emitted.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the user did not recognize that lamp was blown or did not know how to replace lamp.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The following fields have been populated: d8.Correction to g3 of the initial medwatch.The aware date should be 18-jun-2020.Olympus will continue to monitor the field performance of this device.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: 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: 11155015
• MDR Text Key: 243477518
• Report Number: 8010047-2021-01238
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

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
• Device Operator: Health Professional
• Device Model Number: CLH-SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/14/2021; 10/02/2022
• Supplement Dates FDA Received: 02/11/2021; 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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