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

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.Olympus checked the subject device but there was no abnormality in the subject device so far.The subject device also recorded no error log.Olympus is continuing the investigation because the cause of this phenomenon is not determined yet.There were no further details provided at this time.Olympus will submit a supplemental report when the result of this evaluation is found.

Event Description

During the laparoscopy-assisted distal gastrectomy, the subject device stopped insufflation 1 minute after the user facility started the procedure.The user facility replaced the subject device to another uhi-4 (the 2nd device), but the reported phenomenon still occurred.In that time, the setting of flow rate mode of the 2nd device was "med".The 2nd device could insufflate the abdominal cavity properly after the user facility set the flow rate mode of the 2nd device from "med" to "high", so the user facility completed the procedure with using the 2nd device.There was no patient injury in this event.

Manufacturer Narrative

Omsc tried to reproduce this phenomenon, but this phenomenon was not reproduced.Omsc evaluated the subject device and confirmed the following.There was no irregularity found in the subject device.There was no abnormality found at the performance of this device.There was no abnormality found at the control function of the insufflation.The phenomenon was not reproduced and the subject device did not have any abnormality, so the exact cause of this phenomenon cannot be conclusively determined.Omsc surmised that the cause of this event was the following in theory.Uhi-4 bleeped the operation sound when this event occurred.So this event caused by the facility pressed the insufflation start/stop switch unintentionally.This device malfunctioned temporally by an unspecified factor.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.

Event Description

As a result of the additional investigation, olympus was received the following information from the facility.The facility doesn't remember the setting value of the cavity pressure.The facility think that the measured value of the cavity pressure did not reach the setting value.The facility doesn't remember that whether the facility pressed the insufflation start/stop switch when this event occurred.The facility did not listen the alarm sounds (e.G.For intra-cavity over-pressurization and/or for the tube obstruction).Uhi-4 bleeped the operation sound, and stopped the insufflation.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• 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: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5522215
• MDR Text Key: 41013362
• Report Number: 8010047-2016-00413
• 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: Initial,Followup
• Report Date: 06/22/2016

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-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2013
• 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