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

Model Number UHI-4

Device Problem Failure to Clean Adequately (4048)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the high flow insufflation unit had foreign matter attached to the board and the function was abnormal.The issue was found during preventive maintenance.There was no patient involvement.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the equipment had pneumatic system piping contaminated with an unknown substance, therefore, the equipment was taken to the uroscience laboratory for inspection.The unknown fluid inside/outside was found on the a-tube, c-tube, and d-tube.These tubes were contaminated, but the other internal parts and main board had no corrosion and appeared to be intact.Visual inspection found hair line cracks on the front panel right below the insufflation connector.The rear panel had multiple rust spots and a dent close to the inlet area.In addition, there was white residue inside the carbon dioxide gas inlet on the back panel.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The reported phenomenon was discovered during preventative maintenance for an unspecified diagnostic procedure.

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 three years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• 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: 16550853
• MDR Text Key: 311606659
• Report Number: 3002808148-2023-02556
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2023

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: 03/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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