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

Model Number UHI-2

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-2 was not returned to olympus medical systems corp.(omsc).The uhi-2 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.During laparoscopic gallbladder excision with uhi-2, the subject uhi-2 suddenly failed to alarm, and no carbon dioxide gas output entered the patient¿s abdominal cavity.The laparoscopic image of organs and tissues displayed on the unspecified monitor was unclear, and the procedure was interrupted.The user replaced the subject uhi-2 with an unspecified manually controlled pneumoperitoneum device and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc).Omsc thought that the user continued to use the subject device since there was no history of repairs with the subject device.The device history record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.However, based on the evaluation result, it was surmised that the reported failure phenomenon was not attributed to the subject device.

• 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: 8498544
• MDR Text Key: 141455142
• Report Number: 8010047-2019-01630
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K953162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR