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

Model Number CLV-190

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation found minor cosmetic damage in which there was a small amount of bare metal showing.This cosmetic damage did not impact the functionality of the device.There was a non-olympus lamp installed, missing heatsink assembly washers and excessive thermal paste.The device had passed functional testing but failed the full inspection due to the missing washers.The 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 cause of the missing washers could not be determined.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.If additional information is obtained at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the image on the evis exera iii xenon light source was flickering during an unknown procedure.The procedure was completed using a similar device.There was no delay in the procedure.During the inspection of the returned device, it was determined the device was missing heatsink washers.There was no report of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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: 13665747
• MDR Text Key: 286557310
• Report Number: 8010047-2022-03941
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2022

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: 10/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• 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