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

Model Number CLV-S190

Device Problem Fire (1245)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

The member of olympus field service department checked the subject clv-s190 and replaced of the examination lamp at the user facility.However the examination lamp did not ignite and the emergency lamp ignited instead.The subject clv-s190 was returned to olympus medical systems corp.(omsc) for the evaluation.Omsc investigated the subject clv-s190 and found the following.-when omsc turned on the subject clv-s190, the examination lamp did not ignite and the emergency lamp ignited in some cases.-even though the examination lamp ignited, the time taken to ignite the examination lamp was longer than the clv-s190 owned by omsc.-even though the examination lamp ignited, the examination lamp did not ignite and the emergency lamp ignited in some cases when omsc switched on and switched off the examination lamp repeatedly.There were no further details provided.Clv-s190 instruction manual states the corresponding method in case of an abnormality.If significant additional information is received, this report will be supplemented.

Event Description

The user inspected the subject clv-s190 before used.When the user ignited the examination lamp of the subject clv-s190, the spark was occurred from the inside of the subject clv-s190.The user rebooted the subject device.However the examination lamp did not ignite and the emergency lamp ignited instead.There was no report of the patient¿s injury and user¿s injury regarding this event.

Manufacturer Narrative

Omsc replaced the power supply unit of the subject clv-s190 with the power supply unit owned by omsc and found the following.Though the examination lamp was turned on and turned off 50 times, the emergency lamp did not ignite.There was no abnormality in the igniting time of the examination lamp.Omsc installed the power supply unit of the subject clv-s190 in the subject clv-s190 again and found the following.Although the emergency lamp was not switched from the examination lamp, the time taken to ignite the examination lamp was longer than the clv-s190 owned by omsc.Omsc also confirmed that there was no mark of the occurrence of the spark (e.G.Burned mark) in the subject clv-s190.Based on these investigations, omsc surmised that this phenomenon was occurred by following.The power required for the examination lamp was not supplied due to the failure of the power supply unit and the emergency lamp ignited.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus received the following additional information.The user prepared for the laparoscopic assisted distal gastrectomy.The user also checked the connection between the subject clv-s190 and the power cord to solve this phenomenon.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6656259
• MDR Text Key: 78233771
• Report Number: 8010047-2017-00760
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

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: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 06/27/2017; 02/20/2019
• Supplement Dates FDA Received: 07/19/2017; 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1