MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH-FLOW INSUFFLATION UNIT; INSUFFLATOR, LAPAROSCOPIC

Model Number UHA-4

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/06/2023

Event Type  Injury  

Event Description

The patient was undergoing right adrenalectomy laparoscopy 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 fingerbreadth below the xiphoid.General inspection of the abdomen revealed no obvious pathology and no injury from the veress needle." at 13:52, the anesthesia record states "saturation and end tidal co2 dropped suddenly after insufflation started.[the surgeon] was notified.The patient [was placed] on 100% oxygen.Ebbs(equal bilateral breath sounds).No crepitus detected.Ett(endotracheal tube) suctioned and patent.Patient easy to ventilate and peak pressures acceptable.No disconnect detected.Orogastric tube in place.Called [another anesthesiologist] for second opinion.Asked surgeon to release pneumoperitoneum.Patient's saturation and end tidal co2 began to rise and stay stable.Aa gradient(alveolar-arterial gradient) and low potassium detected on istat.Proceeded without further incident." the olympus high flow 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 the pneumoperitoneum.The same insufflator and tubing was used for the remainder of the case without any issues.

• Brand Name: HIGH-FLOW INSUFFLATION UNIT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.
• MDR Report Key: 18084965
• MDR Text Key: 327697282
• Report Number: MW5147839
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Public: (01)04953170324147,(11)210902
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

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: UHA-4
• Device Catalogue Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic
• Patient Race: White