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

Model Number UHI-4

Device Problems Erratic or Intermittent Display (1182); Gas/Air Leak (2946); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to (b)(4).(b)(4) checked the subject device and found that the reported phenomenon was duplicated due to the failure of the electrical circuit board.During the incoming inspection for repair of the subject device at (b)(4), it was also found the following.Flow rate check was not good due to defective manifold unit.Moisture came from the first regulator unit.Leakage came from the connector unit.The exact cause of the reported events could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during unspecified timing, it was found that the front panel leds of the subject device blinked.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. the exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc presumed that the cause of the phenomenon was the failure of the main board.The cause of the failure of the main board could not be conclusively determined. the exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc presumed that the cause of the phenomenon was the failure of the manifold unit.The cause of the failure of the manifold unit could not be conclusively determined. the exact cause of the reported event could not be conclusively determined. based on the reported information, omsc presumed that the cause of the phenomenon was the broken connector.The cause of the broken connector could not be conclusively determined.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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12968325
• MDR Text Key: 285687346
• Report Number: 8010047-2021-15813
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1