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); Output below Specifications (3004)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The evaluation could not duplicate the user report.The unit was tested with a test cv-190 video processor and three different scope types.The b30 error did not occur during testing.The unit passed all functional tests.The evaluation did find the lamp had 300+ hours and the light output was below specifications.The lamp was replaced.The customer was advised to check their scope, video processor, and cable connection for possible causes of the error.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported an evis exera iii xenon light source had a b30 "scope communication" error during preparation for use.There was no patient involvement or impact to patient care reported for this event.

Manufacturer Narrative

This follow up report is being drafted to include the device history record(dhr) review and the following sections ,h4, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.The probable cause is failure to dry the electrical contacts of the video connector adequately or with connecting the device with dust and dirt attached to the electrical contacts.In circumstances when dust and dirt are attached to the electric contact point, the communication between the video processor and the scope becomes difficult.As a result, b30 communication error occurs.The instructions for use (ifu) regarding the drying of electric contacts states: make sure that the video connector and its electrical contacts are completely dry before connecting the plug to the video system center.If they are wet, wipe them as wet equipment could cause the image to flicker or disappear.Olympus will continue to monitor complaints for this device.

• 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
• MDR Report Key: 11556121
• MDR Text Key: 241934320
• Report Number: 8010047-2021-04079
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: 03/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1