MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE; ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED

Model Number CLV-190

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

An olympus representative reported on behalf of the customer that their was an exhaustion of their battery unit on their evis exera iii xenon light source device.When the device was received for evaluation by an olympus repair facility, it was discovered that the light source lamp failed, and that the customer was using a lamp that was not designated for use with the light source by olympus.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, it was discovered that the customer had installed a lamp that was not approved by olympus for use with the olympus light source, and that the lamp was flickering and not lighting properly (lamp failure).The customer's originally reported issue was not confirmed.The investigation is ongoing, and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation the specific cause of phenomenon could not be identified.It is likely the non-olympus bulb contributed to the customer's reported issue.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿pre-use inspection: when the emergency light indicator on the operation panel lights switch the product off and then on again so that the illumination lamp lights up again.If the emergency light indicator still lights up, replace the light lamp with a new one according to section 6 "replacing the light lamp".If the emergency light indicator still lights up, contact olympus.4.6 check the illumination light 3 confirm that illuminated light is discharged from the tip of the endoscope.To "500h" of lamp usage time indicator if you feel that the light is dark even if it is not illuminated, replace the light lamp with a new one according to section 6 "replacing the lighting lamp"."chapter 6 replacement of illuminating lamp 6.1 light lamp replacement summary and precautions replace the illumination lamp with the one specified below.Xenon lamp maj-1817 (olympus) if you need a new illumination lamp, contact olympus.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16372083
• MDR Text Key: 309503166
• Report Number: 3002808148-2023-01396
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: 01/16/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• 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