MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE

Model Number CLH-SC

Device Problems Optical Problem (3001); Output Problem (3005)

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

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

During a call with tac (technical assistance center) engineer support, customer was provided with the correct part number for the lamp replacement.Customer did not require any additional assistance and no other issue was reported.To date, customer did not report any issue after the part number replacement was provided.This report will be supplemented accordingly following the investigations.

Event Description

A report of lamp failure, needs a replacement lamp prior to an unknown procedure was reported.There was no patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Device history records was unable to be checked as the subject device was manufactured more than 15 years ago.Year of manufacture: 2003 delivery date: 2003/7/31.Based on the results of the investigation, the phenomenon was due to main lamp deterioration, surmised from the fact that the no contacts was made from customer following the first contact about the lamp.Olympus will continue to monitor complaints for this device.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: HALOGEN LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11769206
• MDR Text Key: 268448128
• Report Number: 8010047-2021-05807
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170024467
• UDI-Public: 04953170024467
• Combination Product (y/n): N
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1