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

Model Number CLK-4

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  Malfunction  

Manufacturer Narrative

The device was not returned to olympus medical systems corp. (omsc), therefore omsc cannot investigate the device. 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. The exact cause of the reported event could not be conclusively determined. If additional information becomes available, this report will be supplemented.

Event Description

At the maintenance of the device, the failure of the power switch and lamp of the device was found. There was no report of patient injury associated with this event. The user facility did not provide other detailed information.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11016992
• MDR Text Key: 227186594
• Report Number: 8010047-2020-10447
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: EI
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/16/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/16/2020
• 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

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse