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

Model Number UHI-4

Device Problems Contamination /Decontamination Problem (2895); Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed by the customer that the exhaust valve did not close.There was no report of patient injury associated with the event.The event date was unknown.

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon could not be duplicated.It was also found that black liquid was in the pipeline due to insufficient reprocessing.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This is a supplemental report to provide additional information.The manufacturing record was reviewed and found no irregularities.Omsc re-evaluated the reported event that the exhaust valve did not close, and judged that it was not reportable.According to the inspection result by sorc, black liquid was in the pipeline, but no other abnormalities were found.The exact cause of black liquid in the pipeline could not be conclusively determined.

Event Description

This report was submitted for black liquid in the pipeline due to insufficient reprocessing found during device evaluation.

• 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: 13166615
• MDR Text Key: 285433710
• Report Number: 8010047-2022-00886
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: 12/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1