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

Model Number CLV-190

Device Problems Communication or Transmission Problem (2896); Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.A faulty scope socket caused the b30 scope communication error.Additionally, corrosion and heavy dust were found inside the scope socket and a worn socket slider switch.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is available.

Event Description

The customer reported to olympus, the lightsource displayed a b30 error during preparation for use for an unknown procedure.The procedure was completed with a replacement device and there was no delay in the procedure.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to include additional information based on device evaluation.The investigation is ongoing and supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

During device inspection, the olympus service center found an additional reportable malfunction.The main power switch would stick intermittently due to an adhesion for foreign material.

Manufacturer Narrative

Correction made to h4.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the defect is likely due to a scope socket failure.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15435459
• MDR Text Key: 306172712
• Report Number: 3002808148-2022-02091
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• 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,Followup
• Report Date: 11/16/2022

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: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 10/28/2022
• Supplement Dates FDA Received: 10/05/2022; 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2015
• 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