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

Model Number UHI-4

Device Problems Free or Unrestricted Flow (2945); Pressure Problem (3012); Fail-Safe Did Not Operate (4046)

Patient Problems Air Embolism (1697); Hemorrhage/Bleeding (1888)

Event Date 05/09/2023

Event Type  Death  

Manufacturer Narrative

A field service evaluation was performed on the device.The device malfunction reported by the customer could not be confirmed as the reported phenomenon could not be replicated.The device has been maintained correctly and all olympus recommendations have been met during the analysis.The co2 primary and secondary circuitry, electrical safety test, verification of the alarms and features, and the motion verification of two cavity modes were all evaluated, and no abnormalities were identified.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during the salpingectomy (therapeutic), the pressure in the cavity exceeded the set pressure at 22mmhg instead of 12mmhg and the alarm did not go off on the high flow insufflation unit.The examination was completed in the expected timeframe using the same set of equipment.However, there was internal bleeding and a gas embolism after the exam noted in the intensive care unit, and the patient died.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, there were no device abnormalities observed by the olympus field service engineer (fse).There were no additional event details obtained, and the device was not returned to olympus for a second expert opinion.Therefore, the root cause of the reported event could not be determined.This supplemental report includes a correction to d9 and h3 from the initial medwatch.Since a device evaluation was performed onsite by an olympus fse, both d9 and h3 have been corrected to ¿yes.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct the h6 problem code and to provide additional information in h7/h9.A formal investigation was initiated to investigate the root cause.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received during an onsite interview with the customer.B5 updated accordingly.Also, olympus performed a review of the recorded data from the reported event.A summary of the findings are as follows: the subject high flow insufflation device (uhi-4) was used for less than 30 minutes.The insufflation was often interrupted (by switching to ¿stop¿) during the procedure, and the total activated time of insufflation was less than 13 minutes.There were three phases during the procedure.During phase 1 and phase 2, it was confirmed that the insufflation pressure increased from 12mmhg to 22 mmhg.Moreover, according to the data in the log file, the following conclusions was determined by olympus: during phase 1: tube obstruction caution was detected.The insufflation needle or trocar tip may not have reached the abdominal cavity, as this occurred at the beginning of this procedure.During phase 2: the overpressure alarm was turned on even though the subject high flow insufflation device (uhi-4) air supply was turned off.It is possible that another gas supply source was used.During phase 3: the lumen pressure was maintained at or below the set value.The flow rate was continuously measured at 5-10l/min.The airtightness of the abdominal cavity was incomplete, and the subject high flow insufflation device (uhi-4) continued to insufflate gas.In addition, it was confirmed that the insufflation pressure was programmed by the user to 12 mmhg prior to the start of the case.The insufflation pressure was not changed during the procedure.Per the log file, the expressive pressure caution was activated four times, and the tube obstruction caution was activated eight times.Alarms are notified to the user by alarm sounds and display (lamp light).It was determined that a small insufflation from the subject high flow insufflation device (uhi-4) resulted in an overpressure of more than 20 mmhg during phases 1 and 2.Therefore, since the abdominal pressure significantly increased with such small insufflation, it is likely that the insufflated space (patient¿s abdomen) was very small.There was no gas insufflation from the subject high flow insufflation device (uhi-4), but the pressure increased to over 20 mmhg.This indicates that the cause was likely another air supply source or an external force.Furthermore, an onsite inspection and maintenance of the subject high flow insufflation device (uhi-4) was performed on 30may2023.During inspection, the following was evaluated: co2 primary and secondary circuitry, electrical safety test, verification of the alarms and features, and the motion verification of two cavity modes.There were no abnormalities identified.Finally, per the log file, it was noted that the subject high flow insufflation device (uhi-4) used during this reported event was also used in a previous procedure on 12apr2023 without issue.

Event Description

On 13oct2023, the following additional information was provided by the customer: the subject device is currently not in use at the facility.However, the facility does have other high flow insufflation devices (uhi-4).Reportedly, the user determined that the insufflation pressure was higher than the set value by looking at the actual pressure display.The user did not do anything to release/reduce the pressure.On 16oct2023, the following information was obtained during an onsite interview at the facility: an olympus representative interviewed a surgeon at this facility.Although he was not the surgeon who performed the procedure, he was able to provide some indirect information regarding the reported event.It was disclosed that the surgeon who performed the procedure has recently retired.During the interview, it was stated that the high flow insufflation device (uhi-4), and all other medical equipment used during the procedure, was "not the key issue" in the event.Although the trocar placement was mentioned, the surgeon refused to provide any specifics.However, he did confirm that the patient was obese.An olympus representative also interviewed a biomedical engineer at the facility to discuss the reported event.The serial number of the subject high flow insufflation device (uhi-4) was verified, and it was observed that the relief mode was set to ¿on¿ in the system.It was stated that during the procedure, the display setting was switched to a ¿minimalistic¿ view and the flow rate information was not shown.The disposable filters and tubing used during the procedure were confirmed to be third-party devices.Prior to this reported procedure, the subject high flow insufflation device (uhi-4) did not cause any known issues.In addition, the other two high flow insufflation devices (uhi-4) used at the facility work without issue and are currently in use.The biomedical engineer also noted that the patient was obese, and that the trocar placement and patient¿s artery damage "was an issue" during the procedure.Moreover, it was stated that after identifying the complication, while attempting to transfer the patient from the operating room table to the intensive care unit (icu), the transportation bed broke (specifically the lifting /table height adjustment function broke).Furthermore, a case was opened by the hospital¿s quality management department to analyze the reported event in may 2023; however, the case was closed in june 2023 because all checks were completed on the subject device with no technical errors identified.According to the biomedical engineer, the nurse involved in the event stated that the device¿s alarm did not sound during the procedure.

• 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: 17121206
• MDR Text Key: 317110538
• Report Number: 3002808148-2023-05914
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/19/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 06/23/2023; 10/13/2023; 11/14/2023
• Supplement Dates FDA Received: 06/28/2023; 11/09/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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
• Patient Outcome(s): Death