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

Model Number UHI-4

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The olympus asset device, high flow insufflation unit, was sent to the olympus service center.Upon inspection and testing of the returned device, it was discovered there was a missing power switch and a damaged top cover.There was no patient involvement.The medical device report (mdr) is being submitted to capture the reportable malfunction of the power switch failure found during evaluation.

Manufacturer Narrative

The asset device was returned to olympus.Upon inspection testing of the returned device, the missing power switch and damaged top cover were replaced.In addition, there was notable damage to the front panel screw receptacle.The review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The investigation could not identify the cause of the missing power switch.No fault was confirmed after the troubleshooting the device.The instructions for use cautions the user on the handling of the device to prevent this type of failure: ¿hitting the equipment with an object or handling it violently may cause malfunction.Always handle the equipment carefully.¿ investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.Olympus will continue to monitor the field performance of 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: 14525979
• MDR Text Key: 300827196
• Report Number: 8010047-2022-09068
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• 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: 03/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2012
• 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