MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION OLYMPUS VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device is not returned to olympus yet.Olympus will investigate the subject device to determine the cause of this phenomenon after olympus receives it.Olympus also checked the device history record of the subject device, and there was no irregularity found.Olympus will submit a supplemental mdr report after the cause of this phenomenon is determined.

Event Description

Olympus was informed that the subject device shut down suddenly during unspecified procedure.The subject device could not turn on again after the event occurred.The facility completed the procedure after replacing the subject device to another device.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2015-01125 to provide device evaluation results.The subject device was returned to olympus for evaluation.Olympus could reproduce this phenomenon and confirmed the subject device worked properly with replacing the power supply unit of the subject device to another one.Olympus also confirmed the power supply unit worked properly to replace the fuse of this unit to another fuse.The screw near the power supply circuit of the subject device got rusted.However, it was not identified whether malfunction of the fuse was related to the rusted screw.There was no abnormality in the appearance of the subject device except the rusted screw, so olympus could not determine the cause for malfunction of the fuse.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS VISERA ELITE XENON LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5229324
• MDR Text Key: 31357799
• Report Number: 8010047-2015-01125
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2013
• 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