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

Model Number CLK-4

Device Problem Output Problem (3005)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the reportable malfunction, the following were noted: the power switch was cracked; there was corrosion on the chassis and the top cover; due to poor contact of the lamp socket, the lamp did not light up.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that the halogen light source had no current coming from the board.The issue was found during preparation for use.There were no reports of patient harm.

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 provided was incorrect.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the investigation results, the cause of the event occurred due to a contact failure of the lamp socket.However, the specific root cause of this failure could not be determined at this time.Olympus will continue to monitor field performance for this device.

• 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: 18132848
• MDR Text Key: 328069665
• Report Number: 3002808148-2023-12830
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024528
• UDI-Public: 04953170024528
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/17/2024
• 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