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

Model Number CLV-190

Device Problems Misconnection (1399); Communication or Transmission Problem (2896)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the front panel mouth was cracked, and there were deep scratches on the top cover with metal exposed.There was corrosion inside the scope socket tubing.The non-olympus lamp life meter was reading over 500+ hours, the lamp life was expired.There was one missing lamp washer.The third party lamp upon inspection had damaged thread-holes.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.

Event Description

The customer reported to olympus, that the light source had a b30 scope communication error.The issue was found during preparation for use before the diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over five (5) years since the subject device was manufactured.The costumer`s complaint was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it¿s likely that the threaded holes were damaged during a lamp replacement by a third-party repair service, based on the observed damage to the thread-holes of the lamp provided by the third party.The event can be prevented by following the instructions for use which state: the light source does not contain any user-serviceable parts.Do not disassemble, modify or attempt to repair it; patient or user injury, equipment damage, and/or the impossibility to obtain the expected functionality can result.Some problems that appear to be malfunctions may be correctable by referring to chapter 8, ¿troubleshooting¿.If the problem cannot be resolved using the information in chapter 8, contact olympus.The light source is to be repaired by olympus technicians only.Olympus will continue to monitor field performance for this device.

Event Description

During the inspection and testing of the returned device, it was observed that the third-party lamp had damaged thread-holes resulting in the lamp not being secured properly.This report is being submitted for the b30 error, as well as the event found during evaluation.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18388527
• MDR Text Key: 331484398
• Report Number: 3002808148-2023-14674
• Device Sequence Number: 1
• Product Code: NWB
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: 12/13/2023
• 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: 12/22/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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