MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem Unable to Obtain Readings (1516)

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 and the reported issue was confirmed.The issue was due to a faulty printed circuit board.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that during a procedure, the flow rate and volume went blank on the front display when the high flow insufflation unit was activated.No patient harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It is likely that the event was caused by the detection of an abnormality in the internal circuit and it is likely the cause of the abnormality in the internal circuit was that the pressure sensor mounted on the main board had failed.It is likely the cause of the failure of the pressure sensor mounted on the main board was one of the following process abnormalities.Oxygen entered the device and the electrode part of the pressure sensor was oxidatively corroded.Due to the oxidative corrosion, the wiring inside the pressure sensor was peeled off.Foreign matter (epoxy) was attached due to a mistake in mounting the parts, and the wiring inside the pressure sensor was peeled off due to the adhesion of the foreign matter (epoxy).The instruction for use (ifu) states the following guidelines: chapter 7.1, "how to identify the cause of an abnormality and how to deal with it" has the following description.· abnormal content: all leds are off · cause: an abnormality has been detected in the internal circuit of this product.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11612827
• MDR Text Key: 243730670
• Report Number: 8010047-2021-04588
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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: 03/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1