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

Model Number CLV-190

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This referenced light source was returned for evaluation.The service group could not confirm the reported "communication error code b30." the unit was tested with a test 190 series video processor with 190 series endoscopes and the b30 error did not occur during testing.However, a worn out scope socket slider switch was found causing intermittent use of high intensity mode, worn out socket air joint leaking air pressure, and corrosion in the air pump and tubing.The light source was repaired back to specifications and returned to the customer.A review of the light sources repair records indicates the scope has had no previous repairs performed.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product was shipped on january 31, 2018.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be that the user connected the scope connector to the output connector without drying it completely, leading to temporary failure in the connection or that there were some issues not with the subject device but with other devices (such as video processor, videoscope, or digital light source cable).Unstable electric contacts of the connector could cause failure in communication between the videoscope and the video processor, resulting in err b30.Olympus will continue to monitor the field performance of this device.In regard to the drying of the scope connector, the following was described in the instruction for use, which could mitigate the risk of damaging the scope connector.Before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts are completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and light source may malfunction.

Event Description

The service center was informed by the customer that during preparation for use, the evis exera iii xenon light source displayed a communication error, code b30.No patient injury or harm was reported.

• 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: 10895020
• MDR Text Key: 220446958
• Report Number: 8010047-2020-09380
• Device Sequence Number: 1
• Product Code: NWB
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2017
• 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