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

Model Number CLV-190

Device Problem Optical Problem (3001)

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

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting the unit.The customer reported the lamp was replaced last month and the lamp is at 200 hours with the auto and brightness setting in the middle at 0.Tac instructed the customer to ensure the light source cable was secure on the cv-190 and clv-190.The customer pushed in on the cable and heard a click.Tac instructed the customer to obtain a scope and test by cupping hand and moving scope in and out, customer stated it is much better.The customer reported that they have cases tomorrow, and will test in the procedures.Tac reported that three unsuccessful attempts were made to follow up with customer and the issue was considered resolved.In addition, the unit was not returned to the service center for evaluation.A review of the instrument history did not show a service/repair for this unit since the date of purchase on (b)(6) 2019.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The user facility reported that for the past month the clv-190 is not auto adjusting the light.The light is too bright during lower and upper endoscopy procedures.There was no patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: the following was surmised based on the investigation results.·the indicated phenomenon was caused temporally by malfunction of the digital light source cable or poor communication.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.

• 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: 11863103
• MDR Text Key: 251931669
• Report Number: 8010047-2021-06604
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• Combination Product (y/n): N
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1