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

Model Number CLK-4

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to the service center for evaluation.The device was sold on july 18, 2004 with no repair records.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was performed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential cause of the reported lamp deterioration/failure is due to long-term use, or the illumination optical system failed.

Event Description

During preparation for use, the light from the halogen light source was not shinning through the scope, the light was dim.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-10502.The original equipment manufacturer (oem) performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The date of manufacture of the subject product is unknown, however the product was estimated to be manufactured in either of 1994, 2004, or 2014 because of the product being launched in 1990 and the serial number.It is presumed that at least more than 6 years have passed since the subject product was manufactured and the lamp deteriorated due to long-term use, or the illumination optical system failed.Olympus will continue to monitor complaints for this device.

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 25-mar-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: 11023183
• MDR Text Key: 227158615
• Report Number: 8010047-2020-10502
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024511
• UDI-Public: 04953170024511
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLK-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: No
• 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