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

Model Number UHI-4

Device Problems Defective Device (2588); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure, the device suddenly stopped supplying gas and made gas leak sound.After the user turned off the device, the device made bubble and explosion sounds with sparks and smokes coming out.The user replaced the device to another device to complete the procedure.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation, but was returned to olympus service operation repair center (sorc).Sorc could not duplicate the reported phenomenon.There was no anomaly found during the incoming inspection.However, there was a record that there were water droplets on the side of the main body.According to the service record of the subject device, the power switch was replaced on october 22, 2014.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that the cause of the stoppage of supplying gas was a temporary malfunction of the electrical board inside the subject device, or due to something other than the device.In addition, we presume it is unlikely that the sound of gas leaking, sparks and white smoke, and the explosion sound were attributed to the subject device because no abnormality was found in the subject 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
• MDR Report Key: 10632840
• MDR Text Key: 210009566
• Report Number: 8010047-2020-07251
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1