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

Model Number UHI-4

Device Problem Insufficient Information (3190)

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

Event Date 11/28/2017

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.The exact cause of this phenomenon cannot be conclusively determined, however there is the possibility of this phenomenon is attributed to the handover of the wrong gas bottle to olympus sales representative by the facility nurse without adequate confirmation.Omsc stated that only co2 was allowed in the instruction manual of uhi-4.Omsc checked the manufacture history of the uhi-4, there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed the following.When the fundoplication procedure was performed, the facility nurse gave olympus sales representative the gas bottle.The sales representative connected the bottle to the uhi-4.After the approximately ten minutes, the sales representative found that the wrong bottle (argon gas bottle) was connected to the uhi-4 and he reported to the nurse that argon gas was insufflated to the patient.The argon gas bottle was exchanged to co2 gas bottle 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".

• 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 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7124811
• MDR Text Key: 95833631
• Report Number: 8010047-2017-02004
• 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
• Reporter Occupation: Other
• Type of Report: Initial,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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1