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

Model Number UHI-4

Device Problems Display or Visual Feedback Problem (1184); No Device Output (1435)

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

Event Type  malfunction  

Event Description

An olympus employee reported on behalf of the customer, the high flow insufflation unit segment was having a light-emitting diode (led) problem.There was a seven (7) segment lighting failure.It was always switching.There was no report of user or patient harm associated with this event.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.It was determined that there was an led failure.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

Additional information was provided regarding this event.The failure occurred before procedure.It had been reported that the device was always ¿switching.¿ it was clarified that the customer was referring to the same event, not additional occurrences.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, information provided by the customer (refer to b5 and applicable corrections (h8).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that a faulty light-emitting diode (led) caused the failure, however, its unknown what caused the led to fail.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: 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15713045
• MDR Text Key: 307270598
• Report Number: 3002808148-2022-03771
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• 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: 10/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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