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

Model Number CLK-4

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.Further communication with the customer conveyed that they are not returning the device.Customer did not provide any further details.Investigation is ongoing.This report will be supplemented accordingly following investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

As reported, the light is not working at all.It will turn on but there is no light.User tried replacing two different bulbs.The issue found during an unspecified procedure.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.Further communication with the customer the following information conveyed: procedure was cystoscopy.Had to have the patient come back another day after a loaner scope received.Currently in the process of purchasing a new tower.Investigation ongoing.This report will be supplemented following completion of investigation.

Manufacturer Narrative

Correction to medical device problem code.This report is being supplemented, to provide additional information, based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device, since it is over 15 years old.However, olympus only releases products to market that meet all manufacturing specifications.And final product release criteria.The case is not, due to design.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.Olympus will continue to monitor field performance for 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: 13186147
• MDR Text Key: 288666290
• Report Number: 8010047-2022-01028
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLK-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• 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