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

Model Number CLK-4

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation but was returned to olympus (b)(4).(b)(4) checked the subject device and found that the reported phenomenon was duplicated due to blowout of the thermal fuse.In addition, oekg found the followings.The bottom side of the front panel was broken.The power switch was cracked.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during unspecified timing, it was found that when turn the power on the power switch lamp lit on, but the subject device could not function.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).The exact cause of the reported phenomenon could not be conclusively determined.However, based on the information from oekg, there was the possibility that these phenomena were attributed to the followings.The subject device could not function; it might be attributed the failure of the thermal fuse due to the aging deterioration, or the blown-out of the thermal fuse due to the increasing temperature inside the subject device under the poor condition of the ventilation such as the blocking the ventilation grilles with the other device.The bottom side of the front panel was broken and the power switch was cracked; it might be attributed the repeatedly long-term use because over twenty nine years had passed from the subject device had been manufactured, or the excessive force being applied by the user.Olympus stated the appropriate handling of clk-4 and the counter measures against abnormalities in the instruction manual of clk-4.

• 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: 11429588
• MDR Text Key: 244786956
• Report Number: 8010047-2021-03404
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170024528
• UDI-Public: 04953170024528
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLK-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1