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

Model Number CLV-180

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The repair center was not able to confirm the customer's complaint.The device underwent testing for over 2 hours with the cv-180 video processor and a 180 model scope.The video image functioned normally and without issue.Olympus advised the customer to check their video processor or scope for possible cause of the image loss.The device was repaired and returned to the customer.Based on the investigation, the device malfunction was not reproduced and the root cause was probably due to factors other than the relevant device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The customer contacted olympus to report the scope lost image.The device malfunction occurred during a procedure, but the customer did not report any consequent or impact to the patient.No additional information was obtained from the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on legal manufacturer's final investigation.Based on the legal manufacturers investigation, the cause of the issue is: the age/use of the device; it has been estimated that 13 years have passed since the equipment was delivered, showing deterioration due to long-term use.Additionally, the user did not heed the notice in the manual and installed the incorrect lamp.Ifu: "never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.".

• Brand Name: EVIS EXERA II 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: 11036936
• MDR Text Key: 222412427
• Report Number: 8010047-2020-10659
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1