MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Suction Problem (2170); Pressure Problem (3012)

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

Event Date 06/26/2022

Event Type  malfunction  

Event Description

The subject device was returned to an olympus service center with a report that there were loose parts inside the device.The device is an olympus loaner.There was no patient or procedure involvement.Upon inspection and testing of the returned device, it was observed that suction could not be stopped, insufficient air supply could not be detected, and air supply could not be stopped automatically.This report is being submitted for the malfunctions found during evaluation of the device (suction cannot be stopped, insufficient air cannot be detected, and air supply cannot be stopped automatically).

Manufacturer Narrative

During inspection of the returned device, the reported issue (loose parts inside device) was confirmed.It was observed the dampers of the manifold unit were broken; therefore, the manifold unit could not be held firmly and became loose.During inspection and testing, regarding the issues that the suction could not be stopped, insufficient air supply could not be detected, and air supply could not be stopped automatically, service found that the gas inlet valve sensor and the socket of the suction valve were broken.It was suspected to be caused by some impact from a loose manifold unit during transportation and movement of the subject device.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the phenomena were reproduced.The repair department pointed out that the damper of the manifold unit was damaged, could not hold the manifold unit firmly, and was loosened.Additionally, the gas inlet valve sensor and the suction valve socket of upuhi4cr00 (ru259800) were damaged.It was determined that the damage was caused by some kind of impact from the loosening of the manifold unit during transportation and movement.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15099751
• MDR Text Key: 304559324
• Report Number: 3002808148-2022-00291
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: 06/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• 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