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

Model Number CLK-4

Device Problem Component Missing (2306)

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

Event Date 05/19/2021

Event Type  malfunction  

Event Description

A user facility returned the olympus, model clk-4, halogen light source to olympus for repair due to a report of the "front bezel needs to be replaced." upon inspection and testing of the returned device by the service department, it was noted that the spare lamp was missing.This report is submitted for the malfunction of missing spare lamp.As this was found during in-house service, there was no patient involvement.

Manufacturer Narrative

The device was evaluated by olympus and it was determined the spare lamp was missing.The investigation is ongoing, and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Updates to section h6.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Based on the available information, the investigation determined the likely cause of the missing spare lamp was that the spare lamp was not replaced after replacement of the lamp.As stated in the instructions for use, "always have a spare lamp in spare lamp holder available in case of lamp failure, so that the examination can be completed without hindrance.".

• 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: 12037123
• MDR Text Key: 280572320
• Report Number: 8010047-2021-07789
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024511
• UDI-Public: 04953170024511
• Combination Product (y/n): N
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1