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

Model Number UHI-4

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during a surgery for right mediastinal tumor resection with the subject device, an error occurred.The doctor found that abdominal pressure was higher than set pressure of the subject device.(the pressure was set to 6 but after an error it was changed to 10.) although an error occurred, the device continued to supply co2 to the patient.The pressurized state continued, so the user had to remove the tube from the trocar and manually exhaust co2.During the surgery, the patient's pleura was torn, and co2 flowed through the torn area in the left lung, which excluded the left lung and temporarily oxygen saturation was reduced to 80.The user completed the procedure with the subject device.There was no report of the patient injury other than above.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device, and there was no abnormality of the subject device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined, because omsc could not confirm the phenomenon.Omsc surmised that the reported phenomenon occurred due to the following causes.The suction pressure was set other than the specified value (-39.9 to -53.2 kpa).The effect of the usage environment.

Manufacturer Narrative

H6: heath effect clinical code- pleural tear.This report is being supplemented to provide h6 problem code and to provide additional information in h7/h9, and to correct missing information inadvertently left out of previous reports.A formal investigation was initiated to investigate the root cause.

• 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: 11782119
• MDR Text Key: 275993780
• Report Number: 8010047-2021-05915
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• 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: 04/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other