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

Model Number UHI-4

Device Problems Gas Output Problem (1266); Defective Component (2292)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested from the reporter.The device was evaluated by olympus.The evaluation found that the allegation of failure to increase pressure during the procedure was not confirmed, but the issue with the bad front panel display was confirmed.It was noted that the panel display issue was caused by a component failure in the light-emitting diode control circuit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported that during a procedure, the high flow insufflation unit was experiencing a failure in pressure that would not increase during surgery and a bad front panel display.No patient injury or procedure impact reported.

Event Description

The problem occurred during a therapeutic procedure.The intended procedure was completed with the same device with a delay of approximately one (1) minute.It was unknown if the device was inspected before use.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer (see updated sections b3 and b5) and the results of the legal manufacturer¿s investigation.Device history records: the device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Complaint history review: there were no complaints of events that were the same or similar to the reported events at the same facility and on the same device.As a result of confirmation, there were no similar complaints.Conclusion: the root cause could not be identified.Based on the results of the legal manufacturer¿s investigation, the "abdominal pressure not increasing" was not confirmed, making it not possible to identify the root cause.Based on the results of the legal manufacturer¿s investigation, the lighting failure was likely to have been caused by a faulty front panel.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 (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: 15830983
• MDR Text Key: 307715763
• Report Number: 3002808148-2022-04408
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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: 10/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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