MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-3

Device Problems Degraded (1153); Erratic or Intermittent Display (1182); Restricted Flow rate (1248)

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

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported on behalf of the customer, during preparation for use, the high flow insufflation unit had a flow rate issue.The insufflation was too low for the procedure.No patient harm reported.

Event Description

During device inspection, olympus found the flow rate light emitting diodes (leds) started blinking intermittently, which is also a potential adverse event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The device was returned to olympus and inspected.The customers report of insufflation too slow to continue the procedure was confirmed and found to be caused by a leakage from the electric flow unit.In addition, olympus found the flow rate led's were blinking intermittently occurred due to failure of the main board.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The legal manufacturer identified that the minor rust and corrosion on the insufflation valve is an additional potential adverse event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.B5: updated with additional information identified by the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been nearly 9 years since the subject device was manufactured.The device met all specifications at the time of shipment.Based on the results of the investigation, it was confirmed the event occurred due to a faulty electric flow unit and a failure of the main circuit board.The specific root cause of the rust and corrosion could not be determined at this time.The following information is stated in the instructions for use (ifu) which may have prevented the event: improper use will not only impair functions and prevent optimum performance, but may cause equipment damage and/or complications.Before each use, always inspect the equipment as outlined in this instruction manual.Olympus will continue to monitor field performance for this device.

Event Description

Additional information was received from the reporter.The intended therapeutic laparoscopy gall bladder removal was completed with a similar, non-olympus device.There was a nominal delay just to change to similar equipment as the high-flow insufflation unit in question was not found with appropriate parameters to proceed the surgery.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the reporter.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14684285
• MDR Text Key: 302395226
• Report Number: 8010047-2022-09982
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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