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

Model Number UHI-4

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 has been returned to olympus medical systems corp.(omsc) for evaluation, however the evaluation is in progress at this time.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that during unspecified procedure, the cavity pressure decreased suddenly and the insufflation from the uhi-4 was stopped.The facility changed the uhi-4 to the other similar device and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

The referenced uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the uhi-4 and found that there was no abnormality and irregularity and could not confirm the user¿s report.Also the uhi-4 did not record any error log.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility of this phenomenon was attributed to the decrease of the flow due to partially clogged tube and/or the inappropriate setting of the uhi-4, or the usage environment of the facility, such as the temporary malfunction due to the noise and/or static electricity.Consequently there was the possibility the error caused that the uhi-4 could not operate correctly.Olympus stated the appropriate handling of uhi-4 and the counter measures against abnormalities in the instruction manual of uhi-4.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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: 7636545
• MDR Text Key: 112447845
• Report Number: 8010047-2018-01219
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

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?: Yes
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 02/20/2019
• Supplement Dates FDA Received: 08/27/2018; 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1