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

Model Number UHI-4

Device Problems No Display/Image (1183); Failure to Power Up (1476); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during an unspecified timing, the front panel of the subject device flickered and the subject device could not supply co2 gas.The facility aborted the procedure.During repair inspection of olympus (b)(4), it was found that the main electrical circuit board of the subject device had failure, the subject device was failed to start and the front panel was not displayed.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined, however based on the previous similar case, omsc surmised that the reported phenomenon attributed to the accidental damage of the pressure sensor on the main circuit board of the subject device.Also, the manufacturer of the pressure sensor had concluded previously that the accidental failure in the manufacturing process had been able to cause the damage of the pressure sensor and its incidence had be rare.Furthermore the manufacturer had already improved the manufacturing process to decrease the incidence of failure further.The damaged pressure sensor in this case was manufactured before the improvement.If additional information becomes available, this report will be supplemented.

• 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: 10354141
• MDR Text Key: 223654032
• Report Number: 8010047-2020-05116
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/01/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1