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

Model Number UHI-4

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Device inspection and evaluation found leakage from the k connector unit.Power supply screws are missing and the threads on the power supply was found deformed and needs to be replaced.The footswitch connector was found damaged.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, parts loose inside the equipment.The issue found during an unknown event.There is no patient involvement associated on this event.Device evaluation found k connector failure.Leakage found from the k connector.This report is being submitted for k connector failure.

Manufacturer Narrative

This report is being supplemented to inform that the additional failure found on the device during evaluation as stated in section b5 above is being reported as malfunction reportable.In addition, the aware date is being corrected from the initial report.The aware date is corrected from january 11, 2022 to january 12, 2022.Investigation is ongoing.This report will be supplemented following completion of investigation.

Event Description

Device return evaluation found footswitch connector damaged.

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, the leakage found from the k connector unit was due to a faulty k connector.However, the definitive root causes of the faulty k connector and damaged footswitch connector could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

This is the demo device.No complaint was received from the end-user.During the initial check by the inspection engineer at the workshop, this issue was found.

Manufacturer Narrative

This report is being supplemented to provide additional information (updates on event reported b5 ).The following sections were updated: b5,g3, g6, h2 and h10.

• 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: 13428378
• MDR Text Key: 295879255
• Report Number: 8010047-2022-02319
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2022

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: 01/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 02/04/2022; 03/07/2022; 04/05/2022
• Supplement Dates FDA Received: 02/10/2022; 04/04/2022; 04/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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