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

Model Number CLH-SC

Device Problem Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is not available for this event at this time.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.The user¿s complaint is confirmed.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.Upon inspection and testing, the user¿s complaint of power light comes on, lamp and fan do not is confirmed.This is attributed due to faulty thermal fuse in the thermal switch.Additionally, the spare lamp was missing from the device.All other functionalities tested ok.The power is supplied from clh-sc in the following order: ¿power inlet¿, "power switch¿, ¿temperature fuse¿, ¿convertor¿, ¿lamp/fan¿.Fault in the temperature fuse causes failure to supply the power to the lamp and fan, and thus the lamp does not light up and the fan is not activated.Since the power switch is connected to the power inlet, the power switch lights up despite faulty in the temperature fuse.The subject device has been used for 10 years or more since it was delivered, and therefore age deterioration caused faulty in the temperature fuse.The user failed to attach a spare lamp to the device after replacing the faulty lamp.

Event Description

As reported for this event, during preparation for use for an unknown event, the device did not work.The power light came on but the light and fan did not turn on.There is no patient involvement and no harm to any patient reported.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.The following sections were updated: b4, d5, e4, g4, g7, h2, h6 and h10.The event date was (b)(6) 2020 and intended procedure was a flexible cystoscopy.There was a 2 minute delay and the intended procedure was completed using another device.There was no patient injury, infection or medical intervention associated with this event.There were no additional error codes, alarms or alert tones associated with this event.The device was inspected before use.

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.Correction to g3 of the initial medwatch.The aware date should be 04-nov-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: 11135298
• MDR Text Key: 234236200
• Report Number: 8010047-2021-01034
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024467
• UDI-Public: 04953170024467
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• 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?: Yes
• Date Device Manufactured: 12/02/2009
• 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