MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem No Display/Image (1183)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the evis exera iii xenon light source would not read 180 and 190 scopes.The issue was found during preparation for use.The patient and equipment were moved to another room, which created a 10 minute delay.The diagnostic procedure was completed without issue.The device was returned for evaluation.During the device evaluation, the device was found to have no image.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the housing front panel mouth was cracked, the top cover was rusted, the front panel chassis was rusted, the bottom chassis was rusted, the lamp door was rusted, the connections socket slider switch was worn out causing intermittent use of the high intensity mode, corrosion was present inside the scope socket tubing, the non-olympus lamp life meter reading was under 50 hours, the light intensity measured out of range, the lamp was missing three washers, the non-olympus lamp upon inspection was observed to have damage thread-holes, and corrosion was present inside the air pump tubing.Based on the results of the investigation, it is likely that the following led to the malfunction: estimated cause of the 180 scope image failure was a failure of the cv-190 patient board.190 scope image failure was not reproduced during the inspection of any of the devices, so the cause could not be estimated.A definitive root cause cannot be identified.The non-olympus lamps were used for less than 50 hours and the light intensity was out of range.All three lamp washers were not attached and the screw holes in the lamps were broken during inspection.A device history review confirmed that the devices were shipped in compliance with the specifications.This issue is addressed in the instructions for use (ifu): the clv-190 instruction manual (figure no.Gt7243) contains the following description, which may prevent the indicated phenomenon.[6.1 replacement of the examination (xenon) lamp].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.[6.2 removal of the lamp].Washers are attached to bolts.Retain all three of them carefully because they will be used again to clamp the new examination lamp.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18422785
• MDR Text Key: 331670088
• Report Number: 3002808148-2023-14917
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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