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 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation at this time, therefore omsc could not evaluate the uhi-4.The uhi-4 was returned to olympus beijing (osh).Osh evaluated the uhi-4 and found that the user¿s report could be duplicated.Osh exchanged the main pc board of the referenced uhi-4 to another main pc board, the uhi-4 operated without any problem.Also, the main pc board of the referenced uhi-4 was installed to another uhi-4, then the uhi-4 could not operate appropriately.The referenced uhi-4 is planned to return to omsc.There were no further details provided.The exact cause of the reported event could not be conclusively determined at this time.If additional information, this report will be supplemented.

Event Description

Olympus was informed that during the hysterectomy procedure, the facility determined that the pressure of the uhi-4 was insufficient.The facility changed the uhi-4 to the uhi-3 and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

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

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-01225 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 confirmed that there was not any abnormal exterior on the main pc board.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.Omsc checked the manufacture history of the uhi-4, there was no irregularity found.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility of the temporary malfunction due to the ingress of the liquid and/or foreign particle into the uhi-4.Olympus stated the appropriate handling of uhi-4 and the counter measures against abnormalities in the instruction manual of uhi-4.Furthermore, omsc is submitting this supplemental report to provide the additional information.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: 7640670
• MDR Text Key: 112857491
• Report Number: 8010047-2018-01225
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1