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

Model Number UHI-3

Device Problems Device Difficult to Program or Calibrate (1496); Improper Flow or Infusion (2954)

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

Event Date 03/10/2024

Event Type  malfunction  

Event Description

It was reported, the insufflation unit had slow insufflation and was not maintaining adequate set pressure.The issue occurred during receipt inspection.There were no reports of patient harm.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field d9, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.The customer's allegation was not confirmed.The presumed cause could not be identified, and a definitive root cause could not be determined.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18989008
• MDR Text Key: 338760229
• Report Number: 3002808148-2024-02926
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K014166
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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