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

Model Number UHI-4

Device Problems Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus (b)(4), it was found that the subject device could not function and generated the alarm sound due to the damage of the main circuit board.The (b)(4) also found that the set/actual flow rate indicator on the front panel was partially missing.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.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, based upon the information from olympus service operation repair center (sorc), there was the possibility that the reported phenomenon was attributed to the abnormality of the internal circuit.For the abnormality of the internal circuit, it might be occurred due to the failure of the pressure sensor mounted on the main board.The cause of the failure of the pressure sensor mounted on the main board is presumed to be 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 part.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: 11070897
• MDR Text Key: 223614291
• Report Number: 8010047-2020-10954
• 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: 01/28/2021

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: 11/30/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1