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

Model Number CLV-190

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Olympus technical assistance center (tac) support spoke to the customer to troubleshoot the device.The customer mentioned that the image was too bright when getting close to objects.The customer was unable to access the unit at time of call so tac instructed to check the automatic brightness feature by watching the distal end of the scope when closer to an item to make sure the light dims.If not, tac advised the customer to make sure the unit is on automatic brightness and to check the light control cable in the back and reseat.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

It was reported the evis exera iii xenon light source is too bright when getting close to a polyp.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.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.Since the subject device was manufactured more than seven years ago, it is presumed that deterioration of parts of the brightness adjustment, impact from control board malfunction or poor light source cable connection contributed in failure of adjusting the brightness.The instructions for use (ifu) states: properly and securely connect all cables.If the cable connector has connection screws, tighten up the screws.Otherwise, equipment damage or malfunction can result.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: 12150747
• MDR Text Key: 280508634
• Report Number: 8010047-2021-08734
• 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: 07/28/2021

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: 06/17/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1