MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-3

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that during a therapeutic laparoscopic total uterine removal surgery, suction occurred on the insufflation unit even though the foot pedal was not pressed.Also, the foot pedal did not respond, and the suction did not stop.The procedure was completed using a similar device.There were no reports of patient harm or impact associated with this event.This report is related to the following linked patient identifiers: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the device evaluation and the investigation, the subject device was evaluated where the reported event was not confirmed and a definitive root cause 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.Because uhi-3 will not continue to be suctioned to a level below 3mmhg for safety function, it is possible that the suctioning by the peripheral equipment was continued.It is likely that the foot switch was not operating because the automatic suction function was working, the insufflation mode was "low" or the abdominal pressure was below 3mmhg.The following is included in the device ifu: "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." "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: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• 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: 18215071
• MDR Text Key: 329081327
• Report Number: 3002808148-2023-13335
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MH-317 FOOTSWITCH.
• Patient Sex: Female