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 is planned to return to olympus medical systems corp.(omsc) for evaluation, however the uhi-4 is not returned to omsc yet, therefore omsc cannot evaluate the uhi-4.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.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during the unspecified surgery, the unspecified beep sound was generated around the uhi-4.However any alarm was not displayed on the front panel of the uhi-4.The facility changed the uhi-4 to the other unspecified similar device and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

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

Manufacturer Narrative

This is a supplemental report to provide the device evaluation results.The referenced uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation could confirm the user¿s report and the recording the error log which indicated the damage of the hydraulic line pressure sensor.There was the possibility of the damage of the hydraulic line pressure sensor was attributed to the inappropriate handling by the user, such as the ingress of the liquid and/or humid air into the uhi-4, excessive impact, and so on, or the accidental breakage of the sensor.Consequently the uhi-4 could not operate correctly then it caused the unspecified beep sound.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.

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7150463
• MDR Text Key: 96126870
• Report Number: 8010047-2017-02153
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

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: 04/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 04/18/2018; 02/20/2019
• Supplement Dates FDA Received: 05/22/2018; 03/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1