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

Model Number	MAJ-1939
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
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 confirm the reported event.There was no abnormality when connecting and operating according to the instruction manual.Based on the results of the investigation, the phenomenon was not reproduced, and a root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The customer reported that during an unspecified therapeutic procedure, the smoke evacuation function was activated, and the pneumoperitoneum pressure decreased, even though the smoke exhaust function was not operated by the foot switch.After the air was sent again and the pressure was released, the procedure was continued and successfully completed using the subject device.There was no patient or user injury reported due to the event.The phenomenon reportedly occurred several times.Additional details were requested regarding the reported events; however, no further information has been provided.This report is for the smoke evacuation foot switch that was in use at the time of the event.The uhi-4 insufflation unit was reported on medwatch 8010047-2022-11906 with patient identifier (b)(6).The maj-591 suction tube was reported on medwatch 8010047-2022-11478 with patient identifier (b)(6).A second issue with the uhi-4 insufflation unit was reported on medwatch 8010047-2022-11907 with patient identifier (b)(6).A second issue with the maj-1939 foot switch was reported on the medwatch with patient identifier (b)(6).A second issue with the maj-591 suction tube was reported on medwatch 8010047-2022-11895 with patient identifier (b)(6).

• 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: 15612153
• Report Number: 3002808148-2022-03210
• Device Sequence Number: 2748572
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 06/17/2022
• 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: 06/14/2022
• Initial Report FDA Received Date: 10/14/2022
• 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: MAJ-591 OLYMPUS SUCTION TUBE; UHI-4 OLYMPUS INSUFFLATION UNIT
• Patient Sex: Unknown