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

Model Number UHI-4

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the laparoscopic colectomy procedure, when the user activated the smoke evacuation foot switch the subject device alarmed and all indicators of the front panel of the subject device went off.The user cycled the power of the subject device, but the all indicators went off again, so the user replaced the subject device to another device and continued the procedure.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject devices have been returned to omsc.Omsc checked the subject device and found that the reported phenomenon was duplicated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause of the indicated phenomenon is that the pressure sensor mounted on the main board has failed.The cause of the pressure sensor failure could not be identified, but it is presumed to be as follows.-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 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.If additional information becomes available, this report will be supplemented.

• 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: 11336144
• MDR Text Key: 232659680
• Report Number: 8010047-2021-02704
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1