MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Corroded (1131); Degraded (1153); Mechanical Problem (1384); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event was investigated by the manufacturer.The device evaluation, review of the device history record (dhr), and review of the instructions for use (ifu) were conducted as part of the investigation.The device evaluation confirmed the user report.It was found a weak ventilation fan caused the main lamp to go off and the spare lamp to turn on.Further, a worn out locking mechanism was not protecting the pins on the scope socket.The top cover was corroded and needed replacement.There was also a non-olympus lamp with 200+ hours measured within specifications.The device was returned unrepaired per request.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: "never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." the root causes could not be identified.Probable causes include the following: - the device is designed under the product specifications so that the examination lamp turns off and that the emergency lamp turns on if an abnormality occurs in the temperature switching circuit.Reduction of the exhaust performance due to wear in the fan might have caused the temperature inside the device to increase, leading to reaction of the temperature switching circuit.Use of the non-olympus lamp might also have caused the examination lamp to switch to the emergency lamp.In light of the fact that more than seven years have passed since the subject device was delivered, the repeated use of the device for a long time caused wear in the fan for exhaust, leading to decrease of the number of revolutions of the fan.- in light of the fact that more than seven years have passed since the subject device was delivered, the repeated use of the device for a long time caused wear in the locking mechanism, leading to malfunction.Olympus will continue to monitor the performance of this device.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Actions are being taken to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

It was reported that, during the procedure, the main lamp of the evis exera iii xenon light source malfunctioned and the device went into spare lamp mode.No patient harm or impact was reported due to this event.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11211310
• MDR Text Key: 233781895
• Report Number: 8010047-2021-01698
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2021

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: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2012
• 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