MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Increase in Pressure (1491); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

Patient Problem Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was retuned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of suspect device: the event described by the customer could not be reproduced.The device did not show any errors during the inspection and a test run also ran without any problems.No errors are stored in the error memory.The report of non-responsive buttons on front panel was not confirmed, panel responded as normal.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during an unspecified procedure using a high flow insufflation device, the access was established, and the unit switched on.Upon switching on the device, co2 was massively pumped into the patient's body in one fell swoop causing the abdominal cavity to inflate greatly.The device kept pumping and could not be switched off.The tube was pulled from the patient.The procedure had to be changed to an open procedure.No further consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the suspect device was reviewed.It was confirmed the device met all design and safety specifications when it was shipped.The definitive cause of the reported event could not be conclusively determined.No device problem was found.

Manufacturer Narrative

This report is being supplemented to correct h4 and h6.Additional information provided in in h7/h9.A formal investigation was initiated to investigate the root cause.Based on the results of the investigation, a definitive root cause could not be determined at this time.However, the following are considered to be potentially related to the root cause of the event: -substantial overpressure occurred due to device failure.Olympus will continue to monitor field performance for this device.

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 investigation, root cause could not be identified although it can be presumed that it was caused by insufflation caused by a large amount of co2 sent into the body.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13693896
• MDR Text Key: 291615089
• Report Number: 8010047-2022-04084
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 03/08/2024; 05/01/2024; 05/08/2024
• Supplement Dates FDA Received: 05/04/2022; 03/12/2024; 05/01/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• 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): Required Intervention
• Patient Sex: Female