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

Model Number UHI-4

Device Problem Leak/Splash (1354)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation found the manifold valve and the device damper were damaged.The faulty parts need replacement to bring back to olympus functional standard.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that, the high flow insufflation unit was leaking.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the event details in section b5.Olympus will continue to monitor field performance for this device.

Event Description

The device is a loaner from olympus.The issue occurred outside of the hospital.There was no patient involvement.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13509568
• MDR Text Key: 296311187
• Report Number: 8010047-2022-02775
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 03/04/2022; 03/28/2022
• Supplement Dates FDA Received: 03/26/2022; 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1