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

Model Number MD-151

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported, the halogen lamp ( md-151 ) did not light when the facility staff replaced it as it was out on the clh-sc (halogen light source).Another new md-151 was used and was noted that it worked without any issues and had no effect on the case.The issue occurred at preparation for use.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

(b)(6).The subject device was evaluated.Device evaluation and inspection, service repair noted the following findings: return device: serial is unknown.Visual inspection: there was something wrong with the appearance.Actual machine confirmation (functional testing ): the defect has been reproduced.(filament is broken) operation check: when connected and operated according to the instruction manual, there are no abnormalities other than the defect found (broken filament).Investigation is ongoing.This report will be supplemented accordingly following investigation.

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 serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the event was caused by a broken filament, but the root cause of the failure cannot be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HALOGEN LAMP
• Type of Device: HALOGEN LAMP
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15198207
• MDR Text Key: 305496300
• Report Number: 3002808148-2022-00773
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170064319
• UDI-Public: 04953170064319
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: CLH-SC HALOGEN LIGHT SOURCE.