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

Model Number UHI-4

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

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the insufflator¿s abdominal pressure was set at 10 at the start of the surgery, but it rose to 48.There was a warning sound and light that continued for about 5 minutes.The physician ordered the smoke evacuation setting to high, and the issue resolved.The issue was found during an unspecified procedure.The procedure was completed with the same equipment and no error code was detected.There was no delay in the procedure.There were no reports of patient harm.

• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18455494
• MDR Text Key: 332546233
• Report Number: 3002808148-2024-00174
• Device Sequence Number: 1
• Product Code: HIF
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 01/05/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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