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

Model Number UHI-4

Device Problems Defective Alarm (1014); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the high flow insufflation unit is having issues showing excess pressure alarms.The issue occurred during the therapeutic laparoscopy procedure which was completed with no delay and the same device.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation, and the customer¿s allegation was not confirmed.An olympus field service engineer (fse) was onsite to inspect the device and found that the device was working as intended and showed no signs of the alleged issue even during a procedure.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being submitted to provide additional information obtained from the customer (d10 and h10) and to correct d9.The device settings were as follows: pressure: 12- 14mmhg; relief mode setting (on or off): off; alarm delay setting (0s or 4.5s): 4.5s; flow rate setting (high /normal / low): medium.The device was indicated for insufflation pressure 12-14mmhg and the pressure was variable.There was no gas source other than uhi-4 used.The pintchvalve exhausted smoke, the overpressure warning beeped, the overpressure warning light occurred, and the tube clogging warning beeped.The smoke evacuation suction tube was connected.The customer declined providing patient information.The customer determined the intra-abdominal pressure was high because of the equipment warning alarm.

Manufacturer Narrative

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, since no device malfunction was confirmed during evaluation on-site by the technician, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information, to correct the h6 problem code and to provide additional information in h7/h9.The phenomenon was repeated or excess frequency of over pressure, which can also be said as over-sensitivity.The device was inspected at workshop and no issue was found, relevant to pressure sensitivity / alarming.If there is an external abdominal pressure, owing to movement of hand instruments / camera, the pressure alarm beeps for fraction of second.A formal investigation was initiated to investigate the root cause.

Event Description

Additional information was obtained from the customer: the overpressure warning occurred 4-5 times, each lasting 5-6 seconds.The customer was not sure what the measured pressure value was or whether the pressure was stable when the overpressure warning occurred.There was no difference from normal overpressure warning.This phenomenon was peculiar to one case and with one user.The other users did not observe any abnormal behavior of device.This issue has not reoccurred.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Log files were received from the customer.The results of reviewing the logs confirmed that there was no error lag.The most recent logs showed that there was no alarm delay and no abnormality was found.The previous investigation does not change.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: 17798956
• MDR Text Key: 324051739
• Report Number: 3002808148-2023-10217
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2024

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-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 12/14/2023; 12/27/2023; 04/02/2024
• Supplement Dates FDA Received: 11/29/2023; 12/15/2023; 01/26/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Treatment: MAJ-590 TUBING.; TROCAR.