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

Model Number UHI-4

Device Problems Defective Alarm (1014); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

An olympus representative reported to olympus, an overpressure alert sounded intermittently, even when no pressure was applied on the high flow insufflation unit.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer allegation was not confirmed.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer provided additional information: the date of the event was 05dec2022.The name of the procedure was unknown but it was for therapeutic purposed.There was a 15-minute delay in the procedure.The patient was not under sedation during the delay, no health hazard occurred.The procedure was completed after being replaced with another uhi-4 in the hospital¿s possession.The event occurred during surgery.The device was used in combination with otv-s190 and clv-s190, serial numbers unknown.Patient was a 65-year-old, japanese male, weight unknown.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information as well as additional information based on the legal manufacturer's final investigation.Please see the updates in sections.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct the h6 problem code and to provide additional information in h7/h9.A formal investigation was initiated to investigate the root cause.

• 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: 16156821
• MDR Text Key: 307275360
• Report Number: 3002808148-2023-00379
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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: 12/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/25/2023; 11/16/2023
• Supplement Dates FDA Received: 02/13/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Treatment: CLV-S190 (SERIAL NUMBER UNKNOWN).; OTV-S190 (SERIAL NUMBER UNKNOWN).
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian