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

Model Number CLV-190

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

The customer reported to olympus, there was a b30 error that occurred on the evis exera iii xenon light source on two separate days when connected to specific endoscopes.The event occurred prior to an unknown procedure, after the scope was connected and the processor was turned on.There were no reports of patient harm associated with this event.Patient identifiers: (b)(6) (event that occurred on (b)(6) 2021) and (b)(6) (event that occurred on (b)(6) 2021).

Manufacturer Narrative

The customer initially reported to olympus, that the b30 error occurred with all 190 devices.During troubleshooting, the customer was able to determine that two endoscopes had the issue.The electrical contacts were cleaned but the issue was unable to be resolved.The cable attached to the processor was not spiraled.To date, the subject device has not been returned.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been more than 9 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.It was assumed that the cause of the phenomenon occurred due to an unknown issue with the two endoscopes, resulting in the occurrence of b30 communication error with the processor.The instruction manual identifies the following related verbiage: ¿9.2 how to distinguish and cope with anomalies: b30 scope communication failure: i can't communicate with the endoscope.Please stop using it and contact olympus.¿; ¿6.9 operation at the end of the inspection: if you also disconnect the video connector, hold the product with your hand so that it does not move, pull out the video-side connector of the scope cable while pushing the unlock lever of the product downward, and hang it on the scope cable holder.¿ olympus will continue to monitor field performance 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13058446
• MDR Text Key: 286356281
• Report Number: 8010047-2021-16612
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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
• Treatment: BF-1TH190SN (B)(4); SCOPE MODEL UNKNOWN; UNSPECIFIED PROCESSOR