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

Model Number UHI-4

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the reported issue (hose cannot be connected) could not be confirmed or duplicated.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

The customer reported that while attempting to connect the maj-1080 (cylinder hose) to the subject device, the hose got caught in the middle and it could not be screwed all the way into the subject device.The reported issue occurred during inspection of the subject device at the customer site, prior to use.Reportedly, the same hose could be connected to the substitute uhi-4 (high flow insufflation unit) without a problem.Moreover, the hose connected to the substitute uhi-4 could not be connected to the subject device.Hence, the customer suspected an issue with the connector on the subject device.There was no patient or procedure involvement.This report is being submitted for the reportable malfunction of hose could not be connected to the subject device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.The problem was not reproduced.The description ¿cannot be pushed in¿ was likely user¿s misunderstanding since the device does not have to be pushed in.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿inspect the cylinder hose for damage, cracks and other irregularities.Use the supplied wrench to attach the cylinder hose to the co2 gas inlet on the rear panel of the uhi-4.Tighten with a force of 24.5 n m (2.5 kgf m)¿ 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: 15287792
• MDR Text Key: 305527070
• Report Number: 3002808148-2022-01355
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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