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

Model Number UHI-3

Device Problem Gas/Air Leak (2946)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Olympus followed up with the user facility multiple times to obtain additional information regarding the reported event but with no results.The customer¿s trocar was not returned to olympus for evaluation; however, the uhi-3 unit was returned.The reported event was not confirmed.A complete functionality inspection which included leak testing was performed on the customer¿s unit and no anomalies were found.Due to the customer¿s trocar not being returned the root cause of the reported event could not be determined.The instruction provides users several warnings in attempt to prevent patient complications.¿to avoid complications, monitor patient parameters such as endtidal co2, electrocardiogram, body temperature, etc., while using the uhi-3.Confirm that the suction tube is securely attached.If the suction tube becomes disconnected, co2 discharge will not be possible.In this case, further supply of co2 gas will increase the abdominal pressure.If a significant gas leak is noted from within the uhi-3, terminate its use immediately and contact olympus.¿.

Event Description

Olympus was informed that during an unspecified procedure, a significant amount of co2 was injected into the patient (with bolus) resulting in an increased blood pressure.It was reported by the head of surgery that this was due to an air leaked on the insufflation unit's trocar.The intended procedure was completed and the patient's blood pressure was stabilized.Additionally, the insufflation unit was inspected post procedure by the user facility's biomed and he confirmed that the unit could not regulate the volume of gas due to the leak found on the trocar and that the unit compensated by sending out gas at a higher rate.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6061998
• MDR Text Key: 58928618
• Report Number: 2951238-2016-00815
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2016

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: UHI-3
• Device Catalogue Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1