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

Model Number UHI-4

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

The subject uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating subject device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the inguinal hernia repair with the uhi-4, the excessive pressure alarm of the subject device sounded.The user continued and completed the procedure by using the same uhi-4 with adjustment.After the procedure, the user found the subcutaneous emphysema on the patient and transferred the patient to the icu.Thereafter, the patient recovered and was discharged two days later.

Manufacturer Narrative

The subject uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation by omsc, the reported phenomenon of the subject device, excessive pressure alarm, was not duplicated.Also omsc confirmed the subject device and found following.There was no abnormality on the outside and inside of the subject device.The function of the insufflation was inspected and there was no abnormality.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Since the reported phenomenon was not reproduced, the exact cause could not be conclusively determined.The instruction manual of the subject device states the cause of the excessive pressure alarm as follows, and the corresponding method in case of an abnormality.Additional gas insufflation from other equipment.The subject device setting.The patient's condition.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9784690
• MDR Text Key: 189612432
• Report Number: 8010047-2020-01598
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 02/29/2020
• Supplement Dates FDA Received: 03/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization