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

Model Number UHI-4

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found that except for the main switch, the front panel led was not illuminated due to a defective printed circuit board.After changing the printed circuit board, the front panel lights were blinking due to a defective front panel.Leakage was found from the 1st regulator and piping tube.In addition, a secondary leak test failed due to a defective electro-pneumatic proportional valve.The flat table, footswitch connector, rear cover and top cover were all corroded.Minor corrosion was found on the chassis, and the insufflator connector but no leakage; inner tube turned yellow but working okay.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported to olympus by the field service engineer that the display on the insufflator was not showing, only the power switch was illuminated and there was noise coming from the inside of the high flow insufflation unit.The issue was found during a procedure.The procedure was completed using a similar device.There were no reports of patient harm.

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 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of "front panel is not displayed, only the power switch is lit, and noise is generated from the inside" was presumed to have been due to the failure of the printed circuit board (designated as the 'cr' printed circuit board).This issue could not be reproduced, however, and no further cause of this failure could be presumed.The suggested phenomenon of "the front-panel led [light-emitting diode] does not light up except for the main switch" was presumed to have been due to the same cause listed above.The suggested phenomenon of "front-panel lamp flashes after replacing printed circuit board [designated the 'cr' board]" was confirmed by the reporter - it was presumed that the cause was the failure of the front panel, but this could not be further clarified from the data acquired for this investigation.The suggested phenomenon of "leakage from primary regulator" was presumed to have been due to the failure of the primary regulator.As this device was not returned to the manufacturer, a further clarification of cause could not be presumed.The suggested phenomenon of "leakage from pipe unit [designated the 's-pipe']" was presumed to have been due to he failure of the pipe unit.As this device was not returned to the manufacturer, a further clarification of cause could not be presumed.The suggested phenomenon of "failure to meet secondary leak test criteria" was presumed to have been due to the failure of the electro-pneumatic proportional valve.As this device was not returned to the manufacturer, a further clarification of cause could not be presumed.The suggested phenomenon of "flat cable is corroded" was confirmed; however, no further presumption of root cause could be determined from the data acquired for this investigation.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: 15843575
• MDR Text Key: 307685300
• Report Number: 3002808148-2022-04503
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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