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

Model Number UHI-4

Device Problem Mechanical Problem (1384)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus, and based on the inspection conducted by the engineer from the repair center the connection wire of the front panel and cr board are seriously corroded, resulting in the button on front panel failed.The investigation is ongoing, if additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that their olympus high flow insufflation unit was not functioning properly during an unspecified procedure.According to the initial reporter, the flow adjustments on the front panel were not failing.The staff switched to another device to complete the procedure with no harm to the patient and no more than 15 minutes delay.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h3 since the device was returned to olympus.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, corrosion occurred on the connection line between the front panel and the circuit board, so there is a possibility that the button on the front panel failed and malfunction occurred, but it was not possible to determine the cause of the corrosion on the connection line.Olympus will continue to monitor field performance for this device.

• 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: 13550973
• MDR Text Key: 296386252
• Report Number: 8010047-2022-03134
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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