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

Model Number CLV-S190

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The subject clv-s190 has not been returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject clv-s190 to identify the root cause of this failure phenomenon when omsc receives it.The clv-s190 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Just before the start of unspecified laparoscopic procedure (before inserting endoscope, after patient anesthesia), the user confirmed that the illumination light was not output from the subject clv-s190 and e101 error (clv temperature error) occurred.Then, the user found that the cooling fan in the subject clv-s190 was not worked.The user replaced the subject clv-s190 with the spare clv-s190, and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

As additional information of this event, olympus medical systems corp.(omsc) received the followings.The clv-s190 has a total of two cooling fans, one is behind the power supply unit and the other is behind the lamp.At this event, it was confirmed that only the cooling fan behind the lamp was not worked even if the subject clv-s190 was turned on.At this time, it is unconfirmed whether the emergency lamp was turned on or not.The subject clv-s190 was returned to omsc for evaluation.Omsc tried to reproduce the reported failure phenomenon, no output of illumination light, e101 error (: clv temperature error), and not working of the cooling fan, but all reported failure phenomenon could not be reproduced.Omsc confirmed the followings.There was no abnormality found and the cooling fan was worked properly, when the subject clv-s190 was operated.There was no abnormality found, when the electrical voltage supplied to the cooling fan was confirmed.There was no abnormality found, when internal the subject clv-s190 was visually observed.The subject clv-s190 does not have any repair history.The subject clv-s190 was manufactured on 2011.In addition, omsc confirmed followings using the olympus asset clv-s190.When producing a situation where intentionally an e101 error (clv temperature error) was occurred, it was confirmed that each cooling fans were kept working.While an e101 error (clv temperature error) was occurred, it was confirmed the examination (xenon) lamp was forcibly turned off and the emergency lamp was turned on.In addition, when the lamp button was pressed, but the examination (xenon) lamp could not be turned on.When keeping a situation where intentionally an e101 error (clv temperature error) was occurred and operation for about 1 consecutive hour, but it was confirmed that stopping of the cooling fan or the equipment it-self did not occur.The root cause of this event could not be conclusively determined, because the reported failure phenomenon could not be reproduced in the investigation.However, based on the investigation result so far, omsc surmised that the reported failure phenomenon was possibly caused by the following in theory.The cooling fan in the subject clv-s190 stopped due to any factor temporarily.Due to stopping of the cooling fan, the internal temperature of the subject clv-s190 raised and e101 error (clv temperature error) occurred.The examination lamp did not output according to the specification of the clv-s190 as the error occurred.And omsc surmised that temporarily stopping of the cooling fan in the subject clv-s190 was caused by following possibly.About seven years has passed since the subject clv-s190 was manufactured, there might be any influence such as abrasion, deterioration, and others due to aging.The electrical power supply from the circuit board in the subject clv-s190 to the cooling fan might become temporarily unstable due to ambient noise, static electricity, and others.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• MDR Report Key: 7604461
• MDR Text Key: 112285652
• Report Number: 8010047-2018-01162
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR