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

Model Number UHI-4

Device Problem Intermittent Loss of Power (4016)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the high flow insufflation unit has intermittent power.The device shuts down on its own and would not pump after reboot.There were no reports of patient harm.There is no further information given regarding event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a faulty circuit board.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the reported event (device shuts down by itself) occurred due to a faulty printed circuit board (cr board).The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

Event Description

Please see related patient identifier (b)(6) (model uhi-4; serial number (b)(6) for the event that occurred on february 13, 2023.

Manufacturer Narrative

This report is being supplemented to provide a correction to b3 and to provide additional information in b5.Please see updates to b3 and b5.

Event Description

Additional information was received.Which confirmed, the unit failed, during a therapeutic laparoscopic, total hysterectomy.On (b)(6) 2023, the screen went blank and pressure was lost.The staff restarted, the machine and it worked normally without any issue, no harm to the patient.It was sent to biomed for inspection.They couldn¿t find any issue, so it was put back into use.On (b)(6) 2023, the same thing happened, during a therapeutic laparoscopic, total hysterectomy.The device shut down, restarted and they performed the rest of the case without issue.There was no harm to patient.Additional details have been requested, regarding the reported event.At this time, no additional information has been provided.If new information is received, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented, to provide additional information obtained from the customer.

• 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: 16554080
• MDR Text Key: 311588510
• Report Number: 3002808148-2023-02578
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 02/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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