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

Model Number	MH-317
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the foot switch is not working and the pressure decreased.The issue occurred during an unspecified therapeutic procedure.The procedure was completed with a similar device and there were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction suction does not stop was not confirmed.Based on the results of the investigation, a definitive root cause for the event could not be determined.However, it is likely that the automated suction function may have been activated by pushing the patient's abdomen or by continuing overpressure at or above the set 5mmhg for more than 10 seconds due to coupling with the respiratory organ.In uhi-3 instructions for use, 21st edition, p.43, there is a description of the automated suction function."when the abdominal pressure exceeds 5mmhg for the set pressure, the abdominal overpressure warning light is turned on and a warning sound is generated, and if this condition lasts for more than 10 seconds, automated suctioning is performed until the abdominal pressure falls to the set pressure.Foot switch operation is described below on page 45."for safety, when the abdominal pressure is below 3mmhg, when the insufflation mode is low, and when the insufflation is stopped, smoke evacuation does not operate even when the foot is switched.(smoke evacuation does not operate even when the pneumoperitoneum tube is not connected to the patient by inspection, etc.)." olympus will continue to monitor field performance for this device.

• Brand Name: FOOT SWITCH
• Common Device Name: 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: 19086490
• Report Number: 3002808148-2024-03388
• Device Sequence Number: 20614969
• Product Code: HIF
• UDI-Device Identifier: 04953170053627
• UDI-Public: 04953170053627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: MH-317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2018
• 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: MH-317 FOOTSWITCH.; UHI-3 INSUFFLATION UNIT.; UHI-3, MH-317.
• Patient Sex: Unknown