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 Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-3 has not been returned to olympus medical systems corp.(omsc) yet.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

The subject uhi-3 was used for an unspecified laparoscopic procedure.During the procedure, the subject uhi-3 didn¿t work properly and didn't insufflate co2 to the abdominal cavity.The user replaced the subject uhi-3 with another device and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

No fault was found with the subject uhi-3, as a result of investigation by an olympus local engineer.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

Olympus medical systems corp.(omsc) could not investigate the subject uhi-3, because the subject uhi-3 was not returned to omsc.Omsc checked the device history record of the subject uhi-3, and there was no irregularity found.In addition, no fault was found with the subject uhi-3, as a result of investigation by an olympus local engineer.Therefore, omsc judged that the subject uhi-3 meets the specifications.The root cause of this event could not be conclusively determined.However, omsc surmised that the possible cause of this event was any kind of accidental factors in theory.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: 8013305
• MDR Text Key: 125460433
• Report Number: 8010047-2018-02077
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1