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

Model Number CLH-250

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject clh-250 has been returned to olympus medical systems corp.(omsc) for evaluation, however the evaluation is in progress at this time.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that during the unspecified timing, the subject clh-250 emitted smoke.There was no report of the user¿s injury and the patient¿s injury regarding this event.Olympus repair center checked the subject clh-250 and found that there was the accumulation of dust inside of the clh-250, one of the two cooling fans was malfunctioned and the lamp did not light sometimes.However the clh-250 did not emit smoke.

Manufacturer Narrative

This is a supplemental report to provide additional information.Olympus medical systems corp.(omsc) was received following information.The failure phenomenon occurred during an unspecified procedure.The user replaced the subject device with another device and completed the intended procedure.There was no report of the user¿s injury and the patient¿s injury regarding this event.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc turned on the subject device but the subject device did not emit smoke.Omsc found that there was the accumulation of dust inside the subject device and one of two cooling fan did not work due to the accumulation of dust.The device history record could not be reviewed because over fifteen years have passed since the subject device was manufactured.Based on the investigation result so far, omsc surmised that the reported phenomenon was attributed to the accumulation of dust.The clh-250 instruction manual states that the corresponding method when there is an abnormality for the device and also cleaning procedure.

• 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: 9132603
• MDR Text Key: 165050976
• Report Number: 8010047-2019-03410
• Device Sequence Number: 1
• Product Code: OAY
• Combination Product (y/n): N
• PMA/PMN Number: K981543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLH-250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 09/29/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1