MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION HIGH FLOW INSUFFLATION UNIT UHI-3

Model Number UHI-3

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for investigation, but olympus could not reproduce the phenomenon.There was also no error code logged in the subject device.Olympus could not determine the cause of this phenomenon conclusively.The instruction manual of uhi-3 states that this phenomenon might occur by following factors.For those like children, whose abdominal cavity volume was small , insufflation at a high flow rate might cause the abdominal pressure to exceed the set pressure.Excessive gas was released from other gas supply devices like a laser device.So there was a possibility that the inappropriate handling by the facility and/or the patient's condition caused this phenomenon.Olympus also checked the manufacturing history of the subject device, and there was no irregularity found.The instruction manual of this device already mentions cautions for the device handling and the measures against excessive abdominal pressure.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that abdominal pressure was higher than set pressure of the subject device during unknown procedure.The facility confirmed that the abdominal pressure became a little lower than set pressure after replacing the subject device to another device, so the facility completed the procedure with the replaced device.Olympus was informed that the facility replaced the subject device with another device during the procedure on (b)(6) 2015.

• Brand Name: HIGH FLOW INSUFFLATION UNIT UHI-3
• Type of Device: HIGH FLOW 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: 5219449
• MDR Text Key: 30993819
• Report Number: 8010047-2015-01112
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030194
• 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: Initial
• Report Date: 10/16/2015

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2002
• 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