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

Model Number UHI-4

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, the user was not able to attach the cylinder hose to the subject device.The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon could not be duplicated.The subject device was returned to the user.During assembly of the cylinder hose, the user was not able to attach the cylinder hose properly to the subject device again and found leakage co2.Other detailed information was not provided.There was no report of patient injury associated with the event.This is a report of the first event during the preparation for use.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device, and there was no abnormality of the subject device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined, because omsc could not confirm the phenomenon.Omsc surmised that the reported phenomenon occurred due to the following causes.The cylinder hose was not tightened with the proper strength.The cylinder hose was deformed foreign material adhered to the connection part of the cylinder hose.

Manufacturer Narrative

This is a supplemental report for initial mfr report # 8010047-2021-05356 to correct of b5.Since the reported events occurred on the subject device, we will handle and report these events in this report instead of the second report.

• 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: 11722017
• MDR Text Key: 271147798
• Report Number: 8010047-2021-05356
• 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
• Source Type: distributor,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

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: Other
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/25/2021
• Supplement Dates Manufacturer Received: 04/23/2021; 05/12/2021
• Supplement Dates FDA Received: 05/11/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1