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

Model Number UHI-4

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.The device is returned and an evaluation completed for it.The manufacture date is not available.The user¿s complaint was confirmed.Upon inspection and testing, unknown liquid was observed inside pneumatic system tubes, manifold unit, electro-pneumatic proportional valve, first regulator unit and k-connector unit.All these parts would need to be replaced.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, during a preventive maintenance unknown liquid was detected in the electro-pneumatic hoses.There is no patient involvement and no reported harm to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The root cause for the issue cannot be conclusively determined.However, it is likely that the foreign body (fluid marks) in the entire tract resulted from reflux from the gas cylinder or the tube side.

• 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
• MDR Report Key: 12534217
• MDR Text Key: 273557073
• Report Number: 8010047-2021-12343
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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: 08/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1