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

Model Number CLH-SC

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the light source¿s lamp was fused.The issue occurred during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields b5 and g2(to select health professional).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.The device was not returned to olympus for inspection, and the customer's allegation was confirmed.Based on the results of the investigation, the cause could not be identified.Cause of failure could not be identified either.Olympus will continue to monitor field performance for this device.

Event Description

It was also reported that they keep blowing out bulbs on this.

• 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: 18913266
• MDR Text Key: 337771260
• Report Number: 3002808148-2024-02464
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024467
• UDI-Public: 04953170024467
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: CLH-SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/16/2024
• 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