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

Model Number CLV-190

Device Problems Fracture (1260); Communication or Transmission Problem (2896)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

The referenced light source was returned to the service center for evaluation.The reported front socket is cracked, and scopes are not plugging in correctly is confirmed.The front panel mouth is damaged/cracked.There is heavy corrosion on the contact pins inside scope socket.Additionally, there is corrosion on external top cover, the front panel chassis is rusted and the main power switch housing is cracked.The lamp is out of specification; non-olympus lamp life is reading over 500+hours.Pending repairs.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The technical support engineer was informed by the center director at the user facility that two the facility's evis exera iii light sources from different rooms are showing b30 error messages during preparation for use.Originally, the issue was thought to be caused by the facility's endoscopes but the scopes were repaired and the issue was not resolved.After further troubleshooting, the b30 error messages was determined to be cause by the light source as the front scope socket is cracked and scopes are not plugging in correctly.The light source will be sent in for repair.No patient involvement or harm was reported.This report is for 2 of 2 light sources.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The device was repaired and returned to the customer.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.No device was not returned to the legal manufacturer; therefore, the exact cause of the reported issue could not be conclusively determined.Based on the service evaluation, cracks in the socket and corrosion of the electrical contacts of the connector likely resulted in (b30 scope communication error) from poor connection with the endoscope and may be caused by client handling (excessive force, inappropriate environment placement and storage).As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states the following: - do not use a pointed or hard object to press the buttons on the front panel and/or keyboard.This may damage the buttons.- do not apply excessive force to the video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.- use the light source only under the conditions described in, transportation, storage, and operating environments" on page 105 and, "specifications" on page 105 in the appendix.Improper performance, compromised safety and/or equipment damage may result.- 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 a fire.Olympus will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA III 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: 12390498
• MDR Text Key: 283247521
• Report Number: 8010047-2021-11000
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1