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

Model Number CLV-190

Device Problem Complete Loss of Power (4015)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

In troubleshooting the issue with olympus technical support via the phone, the reporter stated the device would be sent in for evaluation/repair.The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The user facility reported to olympus that the evis exera iii xenon light source had shut down in the middle of a therapeutic procedure.No patient harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and legal manufacturer¿s investigation.The device was returned to an olympus service center for evaluation and the reported issue was not confirmed.However, the evaluation found that the connection had heavy dust/debris blocking the scope socket pins which caused a b30 error.In addition, the device had a non-olympus lamp with over five hundred (500) hours of use and was out of specification.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue could not be conclusively specified.Regarding the issue of the clv-190 light source being shut down, as the issue could not be reproduced by olympus, it was likely that there was a factor such as the capacity of the outlet at the facility was smaller than the total electric capacity of the connected equipment.It was likely that error b30 occurred because dust and dust blocked the pins of the scope socket.The ifu (instruction for use) describes the following: 3.8 connection to the ac mains power supply be sure to connect the power plug securely to prevent unintentional disconnection during use.The equipment will not function.Do not extend a single wall mains outlet into multiple outlets for simultaneous.Malfunction of the equipment may result.Confirm that the hospital-grade wall mains outlet to which the light source is connected has adequate electrical capacity that is larger than the total power consumption of all connected equipment.If the capacity is insufficient, a fire can result, or the circuit breaker may trip, and it may turn off not only the light source but also all other equipment connected to the same power circuit.

• 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: 11763464
• MDR Text Key: 249040828
• Report Number: 8010047-2021-05762
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1