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

Model Number UHI-4

Device Problems No Display/Image (1183); No Flow (2991)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus local service department.The olympus local service department checked the subject device and found that the alarm occurred and the all indicators on the front panel of the subject device went out since the circuit board of the subject device was broken.However, the failure of co2 supply was not duplicated.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the laparoscopic surgery with the subject device, the subject device was alarmed and the all indicators on the front panel of the subject device went out.Then the subject device could not supply co2 to the patient.The subject device was used with otv-s190.The user replaced the subject device with another device to complete 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.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the subject device was not returned to omsc, the exact cause was unknown.Based on the event, it is inferred that the phenomenon occurred since an abnormality was detected in the internal circuit.The cause of the internal circuit malfunction is presumed to be the failure of the pressure sensor mounted on the main board.The cause of the failure of the pressure sensor mounted on the main board is presumed to be 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).It is also inferred that the co2 supply stopped since panel display disappears and the alarm sounds (pressure sensor error) occurred.

• 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: 11736206
• MDR Text Key: 248370242
• Report Number: 8010047-2021-05534
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1