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

Model Number UHI-4

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Initial reporter full hospital name: (b)(6).Health effect - clinical code - subcutaneous emphysema.The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A user facility reported to olympus that during a laparoscopic procedure with the high flow insufflation unit the display went out halfway through inflation.It continued to inflate but no information would show on the display; the error occurred intermittently.It was later stated that this had happened during several procedure causing ¿subcutaneous emphysema¿ in the abdominal area and some to the head (also stated as two incidences).A field service technician attended a later laparoscopic procedure and no anomaly was detected.The technician set the standard pressure values and the surgery was performed without complication.Later in conversation with the surgeon, the surgeon stated they also replaced the trocars with a different model.The extent of the emphysema was unable to be specified.It was stated intervention was needed but specific were unable to be provided.Additional information has been requested, if received, a follow up report will be sent.This issue involves two patient identifiers.Patient identifier (b)(6) is for the first instance of an emphysema occurrence.Patient identifier (b)(6) is for the second instance of an emphysema occurrence.

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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is very unlikely that an olympus device caused or contributed to the patient's development of emphysema.In addition, the report of no display/intermittent error could not be reproduced since the device was not returned for evaluation.Therefore, the root cause of both events could not be determined.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: 16287699
• MDR Text Key: 308706071
• Report Number: 3002808148-2023-01022
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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
• Patient Outcome(s): Required Intervention