MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HALOGEN LIGHT SOURCE

Model Number CLK-4

Device Problems Use of Device Problem (1670); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

The following non-reportable malfunctions were found during the device evaluation: chassis was deformed; two feet were missing; worn out connector; faulty pump unit; broken lamp.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The subject device was returned to an olympus service center with no alleged complaint.Upon inspection and testing of the returned device, a faulty transformer was found and the spare lamp was missing.There was no patient or user injury reported due to the event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during device evaluation.

Manufacturer Narrative

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 the shipping history is unavailable.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the unit would not power on due to a faulty transformer.The definitive root cause was unable to be determined.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported the unit would not power on due to faulty fuse.The issue was discovered at set-up and no impact to patient or procedure.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: HALOGEN LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18194585
• MDR Text Key: 328996470
• Report Number: 3002808148-2023-13239
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024511
• UDI-Public: 04953170024511
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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