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

Model Number UHI-4

Device Problems Display or Visual Feedback Problem (1184); No Flow (2991)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the reported issue (front panel won't display the flow, and the flow rate is always zero) was not confirmed or duplicated.However, it was observed there was dirt in the connecting tube which resulted in failure of a manifold unit.Hence, the device could not insufflate.In addition, service found two feet were missing.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 the front panel of the subject device wouldn¿t display the flow, and the flow rate is always zero.The reported issue occurred during maintenance of the subject device.There was no patient involvement.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the subject device would not insufflate.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the flow rate not being displayed on the front panel was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The investigation confirmed a faulty manifold unity most likely due to dirt on the connecting tube.The specific root cause of the dirt could not be determined at this time.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: 15237688
• MDR Text Key: 305361973
• Report Number: 3002808148-2022-01077
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 07/25/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• 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