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

Model Number	MAJ-1939
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing did not reproduce the reported issue.No abnormality was observed in the device.Based on the results of the legal manufacturer's investigation, since no problem was found with the device, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that, during an unspecified therapeutic procedure, the smoke evacuation function was activated and pneumoperitoneum pressure decreased, even though the subject device was not used to operate the smoke evacuation function.After reinflation and pressure return, the procedure was continued and completed.There was no effect on the patient due to the event.This report is for the model maj-1939 foot switch.The model uhi-4 olympus insufflation unit was reported on medwatch# 3002808148-2022-03783 with patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Production records were reviewed and the manufacturing date was identified.A review of the device history record found no deviations that could have caused or contributed to reported event.The device shipped according to specifications.

• 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: 15995286
• Report Number: 3002808148-2022-05296
• Device Sequence Number: 5950049
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2012
• 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: OLYMPUS INSUFFLATION UNIT.
• Patient Sex: Unknown