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

Model Number UHI-3

Device Problems False Alarm (1013); Output Problem (3005)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the customer reported issue was not able to be duplicated as no issues found with device during testing.The unit was checked, ensure proper power condition (proper grounding and no voltage fluctuation), found to be working and functional with no issues observed.The unit was kept under observation for seven (7) days and found to be working normal and functional and was checked per the olympus standards and determined to be working satisfactorily.Unrelated to the reported issue, the device was found with scratches on the top cover, chassis, front panel and rust found on the rear panel.Based on evaluation findings, the customer reported issue was not confirmed as no issues found on the device during testing.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported that during an unspecified procedure, the device was found giving an alarm of gas empty even though the gas inlet was not empty.The field service engineer onsite checked the unit and the device showing gas empty after using 5-10 minutes in the procedure.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.

Event Description

Updates on event problem reported.The procedure performed at the time of the event was a lap cholecystectomy.The intended procedure was completed with the same device.No harm or injury to the patient as a result of 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.

• 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: 13716434
• MDR Text Key: 296881617
• Report Number: 8010047-2022-04206
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2008
• 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