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

Catalog Number CLV-S190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

The subjected device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the device and found that the phenomenon was reproduced.Furthermore omsc found that the power-supply unit did not output the lighting voltage for the xenon lamp.Omsc evaluated the power-supply unit and found that the resistance mounted to the circuit board had the marks of heat and the resistance was broken.Omsc replaced this resistance with another one.The power-supply unit outputted the lighting voltage for the xenon lamp appropriately.So omsc surmised that the breakage of this resistance was the cause of this phenomenon.Omsc surmised that the cause of the breakage of the resistance is the following in theory.Any foreign material (e.G.Dust, smother) was attached to a high-voltage generating circuit of the unit that is supplied a voltage from this power-supply unit.An electric charge leaked through any foreign material.The power-supply unit supplied a large voltage unintentionally.As a result, an electrical load in the circuit of the power-supply unit had intensified.The resistance developed fever and the resistance was broken.The (b)(4) instruction manual states the corresponding method when the xenon lamp went out and the cleaning procedure for the device.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.

Event Description

Olympus was informed that the xenon lamp went out and the emergency lamp lighted up during an unspecified ent procedure.As a result of investigation, olympus was informed the following information on march 25th 2016.At this case, the facility replaced the (b)(4) with a spare device made by (b)(4), and completed the procedure.There was no report of the patient's injury regarding this event.

• Brand Name: OLYMPUS VISERA ELITE XENON LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: yutaka yanagawa ; 2951; ishikawa-cho; hachioji-shi, tokyo 19285-07 ; JA 1928507 ; 42 6425177
• MDR Report Key: 5589791
• MDR Text Key: 43167428
• Report Number: 8010047-2016-00494
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2016

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 Catalogue Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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
• Patient Outcome(s): Required Intervention