MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-3

Device Problem Gas Output Problem (1266)

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time.As part of our investigation, olympus followed up with the user facility regarding the reported event and was informed that the information is being gathered to provide an appropriate response.Olympus will continue to investigate this complaint to obtain more detailed information.

Event Description

Olympus received a medwatch report that states patient during a right robotic-assisted laparoscopic nephroureterectomy, insufflation started and the patient became bradycardic and hypotensive leading to pulseless electrical activity (pea) arrest.According to the medwatch, prior to the patient¿s event the veress needle was used to gain intraperitoneal entry.There was no blood visualized or enteric contents with aspiration.The patient was resuscitated and intraoperative transesophageal echocardiography (intraop echo) showed gas in the right heart.The patient was sent to the intensive care unit (icu) and underwent cardiac catheterization.It is unknown if the intended procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the user facility¿s registered nurse.Olympus received additional information from the user facility¿s registered nurse that states the patient had been administered metoprolol and lisinopril for high blood pressure.It is not known if the uhi was gas leak tested.The bar graph level for supply pressure lights were green.No lubricant was used on the equipment/hose connections.It is not known if the gas cylinder confirmed to be closed prior to pressing the start switch.No alarms or alerts were noted.It is not now if when, the gas cylinder's valve was closed did the supply pressure remain the same.Prior to attaching the tubing to the verses needle the insufflator was turned on.The flow rate was appropriate, and the pressure read 0 prior to attaching the tubing to the veress.The tubing was purposefully temporarily occluded with a finger at the end of the tubing to ensure that the insufflator read higher pressures and alarmed appropriately.The cylinder hose for uhi-3 and the yoke were inspected for scratches, cracks and other damage after the incident.The medical gas pipeline adaptor was also inspected for damage after the incident.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the original equipment manufacturer (oem).The oem evaluated the content of this complaint and reported that no complaints have been proposed in the past at the facility.As a result of checking the previous complaint file, there is no similar complaint, and it is a new phenomenon.This may have contributed to the adverse event and/or adverse health effects.The actual product could not be returned, and no abnormalities could be confirmed in the postoperative inspection, so the cause could not be identified.Since there was no problem with the quality check results at the time of shipment, it is considered that there was no manufacturing problem with the device.The severity of harm (in case of ae/pae): as a result of checking the risk management file, the following description was checked.Hazard: hazard due to substance administration.Hazardous state: excess carbon dioxide into idiosyncratic patients.Hazard: complications/poisoning.Serious levels: severe.Frequency of occurrence :3.Risk status :c.The severity of the harm in the risk assessment was "severe", but no abnormality was confirmed in the equipment, and the operation manual describe the indicated phenomenon, so this was not performed.The root cause could not be determined.A review of the dhr was performed and found no abnormalities during the manufacturing process.Although the cause of the event cannot be identified, it is probable that the health hazard was caused by prolonged periods of high intra-abdominal pressure during the operation.As noted in the instruction manual, maintaining the pressure in the abdominal cavity at an excessively high level for a long time may reduce cardiac output.The ifu states as follows ¿dangers, warnings and cautions ¿.Metabolic acidosis and resultant cardiac irregularity.Prolonged intra-abdominal pressures greater than 20 mmhg should be avoided.This can cause any of the following: decreased respiration with compromised diaphragmatic excursion.Decreased venous return.Decreased cardiac output.Acidosis.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8507084
• MDR Text Key: 141735541
• Report Number: 2951238-2019-00734
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVIDIEN SURGINEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 98