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

Model Number UHI-4

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The olympus representative reported (on behalf of the customer) that the high flow insufflation unit olympus asset was inspected before use and had an abnormal flow rate.There was no delay in the patient¿s procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation of abnormal flow rate was confirmed.Device evaluation found the flow display was wrong due to a defective manifold unit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the customer.Please refer to the following sections for the new information: b5, d - concomitant medical products.

Event Description

The thoracic laparoscope that accompanied the high flow insufflation unit was used by the thoracic surgery and the high flow insufflation unit was not used in the procedure.It is the thoracic surgery department that uses the camera system, and the thoracic surgery did not use the pneumoperitoneum.The loaner device was fine when installed.The camera system was not used in abdominal surgery.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the customer¿s allegation was reproduced and confirmed.It was determined that ¿flow volume display is not accurate¿ due to the observed defect of the manifold unit causing the flow volume sensor inside the manifold unit to fail resulting to inaccurate flow volume display.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.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): 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17646830
• MDR Text Key: 322322341
• Report Number: 3002808148-2023-09140
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/30/2023

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: 08/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 10/26/2023
• Supplement Dates FDA Received: 09/22/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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
• Treatment: THORACIC LAPAROSCOPE.