MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. SMOKE EVACUATION FOOT SWITCH

Model Number	MAJ-1939
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the smoke evacuation foot switch exhibited an issue where the foot switch was not pressed.The issue occurred during an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned and the evaluation found the following: smoke evacuation function activated and insufflation pressure decreased even though the footswitch was not pressed; and the smoke evacuation function is malfunctioning due to a malfunction; should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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 investigation, the root cause of the smoke evacuation function activated, and insufflation pressure decreased even though the footswitch was not pressed was due to a broken footswitch cable.Olympus will continue to monitor field performance for this device.

• Brand Name: SMOKE EVACUATION FOOT SWITCH
• Common Device Name: SMOKE EVACUATION FOOT SWITCH
• 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: 18758989
• Report Number: 3002808148-2024-01650
• Device Sequence Number: 12412656
• Product Code: HIF
• UDI-Device Identifier: 04953170324185
• UDI-Public: 04953170324185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-1939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UHI-4
• Patient Sex: Unknown