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

Model Number UHI-4

Device Problem Loss of Power (1475)

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

Event Date 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

E1 establishment address: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the high flow insufflation unit gave an error before the front display turned off after selecting the cavity to be used for an exam.The issue occurred during preparation for use in an unidentified procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: g2 additional information added to field b5, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation of front panel display disappeared after selected cavity mode was not confirmed.Additionally, during device evaluation, it was found that the high flow insufflation unit could not start up.Based on the results of the investigation, the root cause for the customer reported event could not be identified.It is likely that the high flow insufflation unit could not start up immediately due to faulty printed circuit board.Olympus will continue to monitor field performance for this device.

Event Description

The issue occurred during preparation for a therapeutic laparoscopy surgery which was completed using a similar device.There were no reports of delay.

• 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: 19164644
• MDR Text Key: 341513919
• Report Number: 3002808148-2024-03763
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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: ESG-400 ELECTROSURGICAL HF GENERATOR; OTV-S200 SURGICAL IMAGING SYSTEM