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

Model Number UHI-4

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the endoscopic nephrectomy, the device sounded an alarm and the front manel indicators went off when the user turned on it.The user replaced the subject device to another unspecified device to complete the procedure.There was no report of the patient injury other than replacing the device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was not returned to olympus medical systems corp.(omsc) for evaluation.Based upon evaluation on the similar events, omsc concluded that the pressure sensor on the main circuit board of the device was damaged accidentally.The manufacturer of the pressure sensor has concluded that the sensor's failure was attributed to a manufacturing process and the process was corrected.The failed sensor in this event had been manufactured before the correction was implemented.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction manual of the device states the corresponding method in case of an abnormality.

• 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: 10360621
• MDR Text Key: 202601658
• Report Number: 8010047-2020-05234
• Device Sequence Number: 1
• Product Code: HIF
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1