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 10/05/2022

Event Type  malfunction  

Event Description

It was reported "the facility staff attached the halogen lamp (md-151) to the device (otv-si) and lamp did not turn on.The issue occurred at preparation for use.According to the report, the device was replaced as the action taken at the customer site.There is no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

The subject device md-151 ( halogen lamp) was returned for evaluation.Device evaluation has confirmed the customer reported issue.Device evaluation and inspection noted, no abnormalities observed during visual inspection, however, functional testing, noted, the reported problem lamp did not turn on was reproduced , (lamp not lightning).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.Corrected d9, e1 "telephone number" and h8 "reuse" 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 reported event was likely the result of a deformed socket pin or lamp failure by burn.The root cause is attributed to component failure.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: 15726739
• MDR Text Key: 307160200
• Report Number: 3002808148-2022-03787
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: OTV-SI