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 Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the uhi-4 at the current moment.Also, it is not sure if the uhi-4 will be returned to omsc for evaluation.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 at the outset of the laparoscopic cholecystectomy, the power of the uhi-4 shut down without any operation.The facility staff turned on the uhi-4, however the uhi-4 could not be activated correctly with high pitch consistent beep.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 is a supplemental report for mfr report #8010047-2018-00757 to provide the device evaluation results.The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation, however the main pc board which had been assembled to the referenced uhi-4 was returned to omsc.Omsc evaluated the referenced main pc board in combination with the uhi-4 owned by omsc and found that there was no abnormality and irregularity and could not confirm the user¿s report.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility that the supply of co2 to the uhi-4 had some problem, and/or the uhi-4 happened to have some temporary failure accidentally.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 is a supplemental report for mfr report #8010047-2018-00757 to provide the device evaluation results.Omsc checked the device history record of the referenced uhi-4, there was no irregularity found.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: 7463504
• MDR Text Key: 107221174
• Report Number: 8010047-2018-00757
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: PK110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 09/10/2018; 02/20/2019
• Supplement Dates FDA Received: 05/25/2018; 10/03/2018; 03/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1