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

Model Number UHI-4

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The regional repair center was informed that a customer high flow insufflation unit was returned due to a report of "check gas insufflator, does not work" during a surgical intervention.The intended procedure was completed using the same device but by turning the unit on and off several times.There was no delay and no adverse outcome to the patient.The device was returned for service.Upon inspection and testing, the device emits a permanent audio beep after it has started and an e03 error occurs - excessive pressure when inflated due to a defective (cr) board and mainboard.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, it was confirmed that alarm goes off when e03 is reported, and the display of the front panel disappears.No defect inside the device other than the phenomenon pointed out.It was surmised that the phenomenon occurred due to the defective pressure sensor mounted on the main board.The cause of the defective pressure sensor could not be identified.It was recommended to replace the main board.The product standards related to the phenomena was checked and found the following descriptions: classification: 12.Quality standards quality item: 7.Hardware failure quality characteristic: 1.Detecting hardware failure standard: 1.If the following phenomena occurred, hardware failure occurred in order to secure safety.(1) control circuit power voltage failure.(2) standard voltage failure of ad converter.(3) pressure sensor data failure.(4) pressure sensor initialization failure.(5) backup data sum check failure.The instruction manual identifies the following related verbiage: chapter 7.1 ¿troubleshooting guide.¿ ·problem: all leds are turned off.·possible cause: an error is detected in the internal circuitry of the high-flow insufflation unit.Olympus will continue to monitor field performance for this 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12849880
• MDR Text Key: 283079023
• Report Number: 8010047-2021-14857
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2021
• 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: 10/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1