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

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-4 was not returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject uhi-4 to identify the root cause of this failure phenomenon when omsc receives it.The exact cause of the reported event could not be conclusively determined at this time.The uhi-4 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the unspecified procedure, display on the front panel of the subject uhi-4 was disappeared, and the subject uhi-4 could not insufflate co2 into the patient's cavity.The power switch of the subject uhi-4 was on.The user restarted the subject uhi-4.However, this phenomenon was not improved.The user replaced the subject uhi-4 with the similar device and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

Omsc evaluated the subject uhi-4 and found the following.-omsc could reproduce the reported phenomenon which was that the display on the front panel of the subject uhi-4 was disappeared.-according the error log of the subject uhi-4, it was found that the error e03 (which is the error of the pipeline pressure sensor.) was occurred.-there was no foreign material in the pipeline of the subject uhi-4.From the investigation results of the subject uhi-4, omsc concluded that this phenomenon is attributed to the failure of the pipeline pressure sensor of the subject uhi-4.The subject uhi-4 is 6 years and 4 months after production, and it was over the usable life of 5years.Therefore, omsc surmised that the failure of the pipeline pressure sensor was caused from the age deterioration of the subject uhi-4.The uhi-4 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

• 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
• MDR Report Key: 8635313
• MDR Text Key: 145936021
• Report Number: 8010047-2019-01997
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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: 05/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1