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

Model Number UHI-4

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was evaluated at the olympus repair center.The reported issue was confirmed, the manifold unit was broken due to which the gas volume could not be accurately measured.The device history records (dhr) was reviewed and it was confirmed that the device met standards at the time of shipment.A review of the device repair history shows the device was repaired once in the past year, december 29, 2021, due to broken dampers.The investigation by the legal manufacturer determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the physical evaluation, the manifold unit was broken due to which the gas volume could not be accurately measured.The cause of the broken manifold is unknown.In general, the user is required to inspect the device for defects, check the function of all devices and have an alternate equipment prior to use.

Event Description

Olympus (osh) was informed that the asset/loaner high flow insufflation unit reportedly has an abnormal flow.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section h4 was updated.Additionally, correction to d5 and g2.The customer complaint of abnormal flow rate was not confirmed.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): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15306710
• MDR Text Key: 305506367
• Report Number: 9610595-2022-01389
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 4953170324147
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: 08/03/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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