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

Model Number UHI-3

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-3 was not returned to olympus medical systems corp.(omsc).Omsc will investigate the subject uhi-3 to identify the root cause of this failure phenomenon when omsc receives it.The uhi-3 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

(b)(6) informed olympus (b)(4) of the event below on march 13th, 2019.On (b)(6) 2015, during laparoscopic fallopian tube resection using uhi-3, the carbon dioxide flow from the subject uhi-3 rapidly increased, causing excessive abdominal distension of the patient.The patient was pregnant.The phenomenon brought unknown risks to the pregnant woman and fetus.After about 20 minutes of adjustment, the subject uhi-3 worked normally, and the procedure was completed.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc).The user did not provided further information about this event.The device history record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.

• 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: 8489994
• MDR Text Key: 141208273
• Report Number: 8010047-2019-01605
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-3
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR