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

Model Number UHI-4

Device Problems Failure to Power Up (1476); No Flow (2991)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus (b)(4).As a result of the evaluation, the following was confirmed.The phenomenon reported by the user facility was not reproduced.The lower part of the front panel was deformed.The damper was damaged.The device has not been repaired in the last year.The exact cause of the phenomenon that the device did not supply air could not be conclusively determined, since the phenomenon could not be reproduced.However, it may have been caused by a temporary malfunction of the internal board or an influence other than the device.In addition, the device did not turn on due to a failure of the main board.The exact cause of the main board failure could not be conclusively determined, because the device has not been returned to omsc.However, it may have failed due to deterioration over time, because five years and two months have passed since the device was manufactured.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the procedure, the device did not supply air.The device was used in combination with the olympus video system center otv-s7pro.The user replaced the device to another device and completed the procedure for inspection.There was no report of patient injury associated with the event.Olympus then inspected the device at the service department of olympus (b)(4) and found that the device did not turn on due to a failure of the main board.

• 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: 12311229
• MDR Text Key: 266163884
• Report Number: 8010047-2021-10123
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1