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

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Since the subject device has been not returned to omsc for the 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 from the user that the subject device could not insufflate co2 occasionally at the unspecified timing.At the incoming inspection for the repair, olympus (b)(4) checked the subject device but could not duplicate the reported phenomenon.However it was found that the indicator on the front panel of the subject device was disappeared.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was not returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of no insufflation and no image on the front panel could not be conclusively determined.However, the reported phenomena could have been attributed to an abnormality of the internal circuit due to faulty pressure sensor mounted on the main board.The cause of faulty pressure sensor could occurred due to any of the following process errors.Oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to the oxidation corrosion.Foreign matter (epoxy) was adhered due to a mounting mistake of the parts.Because of the adherence of the foreign matter (epoxy), the wiring inside the pressure sensor was peeled off.

• 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: 11052371
• MDR Text Key: 225929959
• Report Number: 8010047-2020-10778
• 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: 02/08/2021

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1