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

Model Number UHI-4

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon was not duplicated, and also found that there was no abnormality on the exterior, and the subject device functioned without any problems when connecting and operating according to the instruction manual of the subject device.The investigation is in progress at this time.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 facility that during the laparoscopic cholecystectomy using the subject device at the user facility, when the insufflation was restarted after temporarily stopping the insufflation, an alarm sounded from the subject device, and the front panel display of the subject device was turned off.Then, when the user cycled the power of the subject device, the subject device restarted, so the procedure was continued and completed.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the error log of the subject device and confirmed the error occurred when the pressure sensor had failed.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Therefore, omsc concluded that the reported event was attributed to the failure of the pressure sensor.The exact cause of the pressure sensor failure could not be conclusively determined, but there was the possibility that the pressure sensor failure was due to any of the following process errors.Oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to the oxidation corrosion.Because foreign matter (epoxy) had adhered to the mounting of the component due to a mistake, the wires inside the pressure-sensor had peeled off due to adherence of the foreign matter (epoxy).If additional information is received, 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: 11327373
• MDR Text Key: 233488116
• Report Number: 8010047-2021-02633
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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?: Yes
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1