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

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject uhi-4 was not returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject uhi-4 to identify the root cause of this failure phenomenon when omsc receives it.The exact cause of the reported event could not be conclusively determined at this time.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

During unspecified laparoscopic surgery, the subject uhi-4 could not insufflate co2 into the patient's body.The physician changed the procedure to the open surgery and completed.

Manufacturer Narrative

The subject uhi-4 was returned to olympus europa se & co.Kg (oekg).Oekg evaluated the subject uhi-4 and found that there was no abnormality and irregularity.Olympus stated the appropriate handling of the uhi-4 and the counter-measures against the irregularity in the instruction manual.There were no further details provided.If significant additional information is received, this report will be supplemented.This supplemental report is also submitting to correct "device product code" of common device name.

Manufacturer Narrative

Olympus medical systems corp.(omsc) was informed additional information as the following.The user agreed that this phenomenon was caused from the inappropriate handling of the device by the user.The additional training was conducted for the user by field engineer of olympus.Therefore, omsc concluded that this phenomenon is attributed to the inappropriate handling by the user.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
• MDR Report Key: 8234781
• MDR Text Key: 132764076
• Report Number: 8010047-2019-00823
• 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: 03/15/2019

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 03/08/2019
• Supplement Dates FDA Received: 02/21/2019; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other