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

Model Number CLH-SC

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center, it was found that the examination lamp of the device did not lighted up.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) has become aware of another failure that the cooling fan was broken.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus local service engineer report that the thermal fuse of the device was broken.Omsc surmised that the reported phenomenon was occurred due to the thermal fuse of the 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: 10676664
• MDR Text Key: 211476536
• Report Number: 8010047-2020-07670
• Device Sequence Number: 1
• Product Code: FAJ
• 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
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: No Information
• Device Model Number: CLH-SC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1