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

Model Number UHI-4

Device Problems No Display/Image (1183); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the unspecified procedure, the front panel display of the subject device was disappeared and the subject device could not insufflate co2 gas.The user cycled the power of the subject device, the issue was resolved.The occurrence date of the event is unknown.There was no patient injury associated with this report.

Manufacturer Narrative

The subject device was inspected at olympus service operation repair center (sorc), but the reported phenomena could not be duplicated.In addition, the exterior of the subject device had no abnormality.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to the manufacturing site of olympus medical systems corp.(omsc) and investigated as follows; >it was filled "date returned to manufacture (d9)" according to the above and was updated "device manufacture date (h4)" this time.[investigation results] it was conducted the investigation using the subject device.-the power was turned on and the air supply operation was performed, but there was no abnormality.-a continuous energization test was conducted, but there were no abnormalities.-the power was turned on and off repeatedly, and the air supply operation was confirmed, but there was no abnormality.-it was repeatedly supplied and stopped air, but there were no abnormalities.-error e03 (pressure sensor failure) was confirmed from the error log.-it was confirmed the inspection report of olympus service operation repair center (sorc) that the reported phenomenon was not duplicated.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.[conclusion] the root cause of the reported phenomenon could not be identified.[consideration] from the investigation results, the cause of the reported phenomenon could not be identified.Although the reported phenomenon was not duplicated, it was presumed from the error log that it occurred due to a pressure sensor failure.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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13379932
• MDR Text Key: 295263233
• Report Number: 8010047-2022-02114
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1