MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION HIGH FLOW INSUFFLATION UNIT UHI-4

Model Number UHI-4

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus.Olympus confirmed that the reported phenomenon was reproduced and the device worked properly when replacing the internal circuit board of the device to a spare circuit board.Olympus will perform further investigation to determine the cause of this phenomenon.Olympus also checked the manufacturing history of the subject device, and there was no irregularity found.The issue is under investigation, so olympus will submit a supplemental mdr report after the cause of this phenomenon is determined.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during laparoscopic assisted distal gastrectomy, the subject uhi-4 insufflated air less than setup condition.The facility completed the procedure to replace the uhi-4 to another device.There was no report of patient injury in this event.

Manufacturer Narrative

Omsc tried to reproduce the subject phenomenon, and the phenomenon was reproduced.Omsc found that the phenomenon was eliminated after replacing the internal circuit board of the subject uhi-4 to a spare circuit board.Omsc investigated this circuit board, but could not identify the failure part.Omsc evaluated the subject uhi-4 and found the following: there was not any abnormality about the behavior of the pressure sensor; there was not any abnormality about the behavior of the cavity pressure control.Based on the above investigation, omsc surmised that the subject phenomenon caused by the following: any adventitious failure occurred in the devices on the circuit board for controlling the insufflation rate.As a result, the subject uhi-4 insufflated air less than the setting value.The uhi-4 instruction manual states the corresponding method when there is an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: HIGH FLOW INSUFFLATION UNIT UHI-4
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: kunimori yamaguchi ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5086303
• MDR Text Key: 26318832
• Report Number: 8010047-2015-00828
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/03/2016

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: Physician
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• 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
• Patient Outcome(s): Hospitalization