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

Model Number UHI-4

Device Problem Connection Problem (2900)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The customer reported that during a chu-be procedure, his olympus high flow insufflation device experienced a connection issue with the o2 supply from the wall of the hospital.According to the initial reporter, the co2 connector was connected to the o2 outlet and consequently, o2 was used for insufflation of the patient.This caused the occurrence of flames while activating the monopolar dissection hook in the abdomen.Reportedly, a flame appeared at the end of the electrocoagulation instrument inside the patient¿s abdomen but was successfully extinguished by smothering it against the patient¿s abdominal fat, avoiding viscera.The staff changed the coagulation instrument, thinking that might have caused the flame issue.However, another brief flame appeared when using the new hook.Following the second flame, the staff re-checked all connections and confirmed that the connector had been inadvertently connected to the o2 inlet and not the co2 inlet.The abdomen was exsufflated, as well as the pipes, then purged with co2.Following those adjustments, the staff successfully completed the procedure using the subject device.There was a 20-30 minute delay, but reported no serious harm to the patient.

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon was not reproduced.The cause, however, was attributed to user¿s handling, triggered by co2/o2 bottle outlet.The territory manager spoke to the nurse who said that the patient was doing ok.For reference see the photo in action item # ga22447478-6 titled ¿uhi-4 high flow insufflation unit made by the rrc ofr¿: the photo shows a single inlet connector which is for co2; next to it "co2 gas inlet" is clearly stated.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.

Event Description

Additional information was received stating that the incident with the patient was reported when the patient was already back at home; the surgeon confirmed there were no consequences to the patient other than the extension of the anaesthesia.

• 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: 15936309
• MDR Text Key: 308090411
• Report Number: 3002808148-2022-04990
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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