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

Model Number CLV-180

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Misconnection (1399); Detachment of Device or Device Component (2907)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, the customers allegation of no scope will hold at all, was confirmed.This was due to the scope socket being worn and having the poor connection.Additional findings were found and are as follows: (a.) the lens base is damaged, (b.) the air and water suction, had debris found inside the air pump tubing, (c.) the charred fuse component on the alternating current inlet of the power supply, (d.) and the front of the panel is damaged, the top cover rusted, the bottom chassis is rusted, the front panel chassis is rusted, the lamp door is rusted.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if additional information is received from the user facility.

Event Description

The customer reported to olympus, that evis exera ii xenon light source, encountered connection issues.¿no scope will hold at all.¿ this event was found during the procedure.The scope had to be held in place to complete the procedure.There were no reports of patient harm associated with the event.Subsequently the device was returned and evaluated and the customers indicated loose connector or connection issue event was confirmed.This medical device report (mdr) is being submitted to capture the electrical/mechanical malfunction found during the evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it was confirmed that: (1) the inlet fuse was burned.Thus, it was determined that the fuse blew out due to a malfunction of the main unit or due to temporary overcurrent.(2) a non-olympus lamp was used.Thus, it was determined that the phenomenon occurred due to misuse.(3): the lens base was broken.Thus, it was confirmed that the damage was caused by strong external impact or vibration.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿ ·5.1 replacement of the examination (xenon) lamp (abstract) always use the examination lamp designated below.To order a new examination lamp, contact olympus.Xenon short-arc lamp md-631.Never install a lamp that has not been approved by olympus.The use of a non-approved lamp can cause damage to the light source and ancillary equipment, malfunction, or fire.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16829179
• MDR Text Key: 314168724
• Report Number: 3002808148-2023-04331
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2010
• 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