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

Model Number UHI-4

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoxia (1918)

Event Date 10/06/2023

Event Type  Injury  

Event Description

Olympus received an fda form 3500 for health professionals reporting an event involving the high flow insufflation unit used in a right adrenalectomy laparoscopy with the patient under general anesthesia.Per the operative note after the time out was performed, a veress needle was placed in the right subcostal area.The abdomen was insufflated to a pressure of 15 mmhg without any adverse hemodynamic consequences.A 5 mm laparoscope was introduced into the abdomen using a 5 mm optical trocar above the umbilicus around 2 fingerbreadths below the xiphoid.General inspection of the abdomen revealed no obvious pathology and no injury from the veress needle.The anesthesia record then documented that at 13:52, the patient's saturation and end tidal co2 dropped suddenly after insufflation started.The surgeon was notified.The patient was placed on 100% oxygen.The patient had equal bilateral breath sounds and no crepitus was detected.The endotracheal tube (ett) was suctioned.The patient was easy to ventilate, and peak pressures were acceptable.There was no disconnect detected and the orogastric tube was in place.Another anesthesiologist was consulted for a second opinion and the surgeon was asked to release pneumoperitoneum.The patient's saturation and end tidal co2 began to rise and stay stable.Alveolar-arterial oxygen (aa) gradient and low potassium were detected on i-stat.There was no further incident reported.The customer noted that the olympus high flow insufflation unit uhi-4 was used during the procedure.This device is subject of an fda class 1 recall because "the unit may over-insufflate (inflate) air into the body with no warning or alarm." per interview with the surgeon in this case, the pressure reading on the insufflator device was within normal limits and there was no alarm.However, the abdomen was tense, and the patient was desaturating.The patient stabilized after releasing pneumoperitoneum.The same insufflator and tubing were used for the remainder of the case without any issue.There was no further patient harm reported.

Event Description

Olympus received further information from the customer.Anesthesia was started at 12:33, incision time was 13:40, and at 13:52, the patient's saturation and end tidal co2 dropped.The patient was discharged on (b)(6) 2023 and is doing well and at baseline.

Event Description

Olympus received further information indicating that the device pressure was set to 15 mmhg, flow rate was set on high, insufflation pressure was indicated for 15 mmhg, and that the indication for insufflation pressure was stable.There was no other gas source used other than the uhi-4.The warning for overpressure and tube clogging did not beep nor did the overpressure warning light occur.The 37-year-old patient had a regular body size and was not obese.It was confirmed that the patient's abdominal cavity was abnormally distended.The overpressure occurred during laparotomy and right adrenalectomy.Insufflation was performed in that cavity and the aforementioned procedure reportedly caused the overpressure.It was determined that the intra-abdominal pressure was high through palpation and due to desaturation of the patient.

• 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
• MDR Report Key: 18182425
• MDR Text Key: 328740935
• Report Number: 2429304-2023-00361
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023,01/02/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2023; 01/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTIVIEW, ETHICON TROCAR; UNKNOWN TUBING
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic