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

Model Number UHI-4

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-4 not returned to olympus medical systems corp.(omsc).There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the unspecified procedure with the uhi-4, the subject uhi-4 could not supply co2 to the patient.The user canceled the unspecified procedure.There was no report of the patient injury other than above.The local engineer reported the following inspection result of the subject uhi-4.-the reported phenomenon was not reproduced.-the log data of the subject uhi-4 showed no errors or dropouts.-the "cavity mode" of the subject uhi-4 was set to small.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-02134.The subject uhi-4 not returned to olympus medical systems corp.(omsc).Omsc checked the device history record of the subject device, and there was no irregularity found.The local engineer reported the following inspection result of the subject uhi-4.-the reported phenomenon was not reproduced.-the log data of the subject uhi-4 showed no errors or dropouts.-the "cavity mode" of the subject uhi-4 was set to small.Since the event was not reproduced, the exact cause has been unknown; however, the following are supposed to be the cause.- the subject device setting and/or user handling.- the patient¿s condition.The instruction manual of the uhi-4 states the corresponding method in case of an abnormality.

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: 8045065
• MDR Text Key: 128263649
• Report Number: 8010047-2018-02134
• 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: 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/30/2018; 02/20/2019
• Supplement Dates FDA Received: 12/20/2018; 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1