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

Model Number CLV-190

Device Problems Communication or Transmission Problem (2896); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.The evaluation confirmed the customer report.In addition, discoloration of the front panel, and peeling-off of the blue plate, faulty scope socket, and missing caution labels were found.A review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The instructions for use (ifu) contains the following statement related to cleaning after use: "if the light source is soiled, perform the following cleaning procedure immediately after use.If cleaning is delayed, residual organic debris will begin to solidify, and it may be difficult to effectively clean the light source.The light source should also be cleaned routinely." the root cause could not be confirmed.Regarding the b30 error, it is presumed that the failure of the output socket caused unstable electrical contacts on the connector and affected communication between the endoscope and the video processor, resulting in b30 error (scope communication err).Regarding the discoloration, peeling off of the blue plate, and missing caution labels, it is presumed that the event occurred because the user did not care for the product after use.In addition, it is presumed that the label was peeled off by the user or the third party.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 the evis exera iii xenon light source displayed a b30 error code.No patient involvement 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: 11156881
• MDR Text Key: 243491396
• Report Number: 8010047-2021-01246
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: 01/12/2021

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: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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