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

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-4 was not returned to olympus medical systems corp.(omsc).Omsc will investigate the subject uhi-4 to identify the root cause of this failure phenomenon when omsc receives it.The uhi-4 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) 2018, during laparoscopic adnexal mass resection, the subject uhi-4 could not insufflate co2 into the patient's cavity.The user replaced the subject uhi-3 with a similar device of other company and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the subject device.The device history record indicates that the subject device has been shipped in conformity to the specifications.The exact cause of the reported event could not be conclusively determined.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 192-8 507; JA 192-8507
• MDR Report Key: 8489993
• MDR Text Key: 141208420
• Report Number: 8010047-2019-01604
• 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
• Type of Report: Initial,Followup
• Report Date: 03/15/2020

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: No Information
• Device Model Number: UHI-4
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/07/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR