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

Model Number	MAJ-1939
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer was performing a therapeutic procedure involving an olympus high flow insufflation unit paired with an olympus smoke evacuation foot switch.During the later part of the procedure, the physician stepped on the smoke exhaust footswitch, and all the gas in the abdominal cavity escaped.Reportedly, the physician waited for the gas to reaccumulate to continue and complete to the procedure.There was no patient harm reported as a result of this event.This report is 2 of 2, submitted to capture the smoke evacuation foot switch.For event 1 of 2, being submitted to capture the high flow insufflation unit, please see report with patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of evaluation and the legal manufacturer's final investigation.From the results of evaluation, it was determined that the suggested phenomenon could not be reproduced, nor confirmed.No anomalies were discovered with the device in question.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, a definitive root cause could not be established.The suggested phenomenon was not confirmed, and no speculative cause could therefore be determined.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15494075
• Report Number: 3002808148-2022-02475
• Device Sequence Number: 1885468
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-1939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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
• Patient Sex: Unknown