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

Model Number UHI-4

Device Problem Insufficient Information (3190)

Patient Problem Bradycardia (1751)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

The device was not 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

A user facility reported during a diagnostic laparoscopic cholecystectomy the patient became very bradycardic during insufflation of pneumoperitoneum while using the high flow insufflation unit.The anesthesiologist was required to vent the ports and administer atropine.The device was inspected prior to use and the procedure was completed with the same device.The procedural delay was considered clinically relevant due to them having to vent the ports before resuming but the exact time was unknown.This mdr requires two reports.The user facility is not sure which unit was used; therefore, the two reports are for both serial numbers.The related patient identifiers are as follows: (b)(6) - high flow insufflation unit, serial number (b)(6).(b)(6)- high flow insufflation unit, serial number 7(b)(6).This medwatch represents (b)(6).

Event Description

Additional information about the event was requested.However, the customer reported having no memory of what happened.

Manufacturer Narrative

Through analyzing log, the following information was confirmed: during the procedure, the tube was clogged.After closing the cock, insufflation was stopped.After insufflation was started, there was tube clogging and there was record of opening cock.Additionally, there were two times of overpressure warning beeps.It is possible, that overpressure was caused by inserting trocar in the beginning of procedure.The leak occurred, from the first half of the procedure and insufflation was conducted sometimes.At the latter half of the procedure, insufflation was increased possibly, due to increase of amount of leak, but abnormal insufflation was not confirmed.Furthermore, the results of the updated investigation did not change from the previous reported results of the investigation.

Event Description

The following additional information regarding the event was received from the customer: the high flow insufflation unit, (uhi-4) was programmed at 15mmhg.The relief mode was confirmed to be ¿on.¿ it is unknown if an alarm delay was set.The setting was started on low flow, then switched to high flow to fill the patient¿s abdomen.Per the surgeon, the insufflation pressure was stable.There was no other gas source (other than uhi-4) used.The smoke evacuation function was not being used during the procedure.The abdominal pressure reached the preset value normally (15mmhg), and the device did not display an overpressure alarm.Also, there was no tube clogging warning alarm noted.There was no abnormal distension of the patient¿s abdomen observed and the intra-abdominal pressure was not determined to be high.The event resulted in a five-minute procedural delay.However, the procedure was reportedly completed with no adverse effects on patient.Per the customer, it is unknown if the event was related to this olympus device.Furthermore, it is unknown if the subject device (uhi-4) was used in a subsequent procedure.The uhi-4 field safety notice was released the following day, and use of all of the uhi-4 devices was stopped per olympus recommendation.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to include information that was inadvertently not included in the initial medwatch.The fields corrected are as follows: a2, a3, b5, b7, g2, and d10.An update has been made to d9 and h3 from the initial medwatch, also, additional information has been added to h4.Although the subject device has been received, the device evaluation and an investigation are still in progress.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 supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide updates to fields (h3, h7, and h9).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The evaluation confirmed the following: the unit passed all tests but recommend recalibration of unit due to nature of fault and full retest of unit.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, a specific root cause of the phenomenon "during a lap chole case, the patient became very bradycardia during insufflation of pneumoperitoneum requiring venting of all gas and atropine by anesthetist" and the phenomenon "approx.5 minute delay to vent co2 from the umbilical port, whilst anesthetist administered atropine" could not be identified with the information received.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: 18356444
• MDR Text Key: 330889521
• Report Number: 3002808148-2023-14465
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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: NON-OLYMPUS 10MM PORT
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female