MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION HALOGEN LIGHT SOURCE

Model Number CLH-SC

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2014

Event Type  malfunction  

Event Description

Olympus was informed that during unspecified procedure the lamp of the clh-sc had gone out suddenly.The physician had interrupted the procedure and exchanged the lamp to new one, but the lamp had not lit.The procedure had been aborted.There was no report of the pt's injury regarding this event.

Manufacturer Narrative

The referenced clh-sc was returned to olympus medical systems corp.(omsc) for eval.Omsc evaluated and found that the thermal fuse in the clh-sc was blown.Also, omsc obtained the info from the facility that the clh-sc was covered with plastic sheet to prevent dust and/or dirt.The air vents of the clh-sc were blocked with the plastic sheet then the clh-sc could not be cooled and was overheated.Then the thermal fuse in the clh-sc was blown and the clh-sc was deactivated.Olympus attributed this phenomenon to inappropriate handling of the device by the user.The clh-sc instruction manual states the notice for the handling of the device.Also, omsc checked the mfr history of the subject device, there was no irregularity found.There were no further details provided.If significant add'l info is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: HALOGEN LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 4080758
• MDR Text Key: 4742692
• Report Number: 8010047-2014-00510
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2014

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: CLH-SC
• Device Catalogue Number: CLH-SC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1