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

Model Number UHI-4

Device Problems Free or Unrestricted Flow (2945); Adverse Event Without Identified Device or Use Problem (2993); Fail-Safe Did Not Operate (4046)

Patient Problem Cardiac Arrest (1762)

Event Date 02/01/2023

Event Type  Injury  

Event Description

"the customer reported to olympus that during a coelioscopic promontofixation surgical procedure, the patient experienced a short episode of a cardiac arrest linked to overpressure of the thoracic cage with the use of the high flow insufflator unit.Additional details have been requested regarding the reported event.This complaint requires five reports.The related patient identifiers are as follows: (b)(6):uhi-4, serial number # (b)(4).(b)(6):uhi-4, serial number # (b)(4).(b)(6):uhi-4, serial number #unknown.(b)(6):uhi-4, serial number #unknown.(b)(6):uhi-4 , serial number #unknown.This medwatch report is for patient indentifier: (b)(6).

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since no device malfunction was confirmed and no further information regarding the reported incident could be obtained, the root cause could not be determined.This supplemental report includes a correction to d4 to provide information that was inadvertently not included on the initial medwatch.Also, information has been added to d8.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information from customer.Updated field.

Event Description

Olympus further received information that this event was considered as vagal response to nocicepti stimulation without consequence at all.No other information provided.

Manufacturer Narrative

This report is being supplemented to provide correction to the initial d8.

Manufacturer Narrative

This report is being supplemented to correct the h6 problem code and h7.A formal investigation was initiated to investigate the root cause.

Manufacturer Narrative

This report is being supplemented to provide a correction to the initial with information inadvertently left out (h7 and h9).

• 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: 16482667
• MDR Text Key: 310675231
• Report Number: 3002808148-2023-02108
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 68 KG