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

Model Number UHI-4

Device Problems Defective Alarm (1014); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Respiratory Problem (4464); Skin Disorders (4543)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, after an unknown therapeutic procedure, the adult patient had subcutaneous emphysema.The patient's condition is unknown and it is not known how the subcutaneous emphysema was treated.The device was inspected prior to the procedure and was in normal working condition.The subject device pressure setting was at 10 mmhg and the flow rate setting unknown.The pressure alert did not sound.The trocar used in the case is unknown.No procedural delay.The customer also stated: on the facility side, smoke exhaust is used with the [off] setting.In addition, it was noticed after the case that the cock of the trucker (to which the smoke exhaust tube was connected) was used in the closed state.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction and the results of the legal manufacturer¿s investigation and the device history record (dhr) review.Correction h10: the attached literature article was initially reported in error as this event did not pertain to literature.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to a temporary failure of the control board as the pressure alert did not sound.Olympus will continue to monitor the field performance of the 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: 15086083
• MDR Text Key: 296408181
• Report Number: 3002808148-2022-00222
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Treatment: BALLOON BRANDT PORT FOR SONIC BEAT LAPARO.
• Patient Outcome(s): Required Intervention; Other