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

Model Number UHI-4

Device Problems Break (1069); Failure to Power Up (1476); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation for asset return.There was no customer complaint reported by the end user.The following events were identified during inspection and evaluation.Event 1: equipment is not getting on.It is due to faulty front panel and main board.Event 2: wires and connectors on the front panel and main board (cr board) are found broken (i.E., physical damage).Event3: threads of k-connector found deformed.Due to that air gas leakage is coming from it.Event 4: internal tubes found deformed/cut, from physical damage.Additionally, the following issues were also found: (a.) wires and connectors of electro pneumatic proportional valve and manifold unit found damage, (b.) wires of pitch valve and foot switch assembly found deformed/cut, (c.) dampers found broken, (d.) deformation(multiple hit marks) found on 1st regulator unit, (e.) tracks of flat cable found rusted.(f.) and heavy dents were found on the s-repair unit.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The high flow insufflation unit was returned to an olympus service center for annual maintenance with no complaint reported by the end user.During inspection, multiple events were identified by olympus staff and are as follows: event 1: equipment is not getting on.It is due to faulty front panel and main board.Event 2: connectors on the front panel and main board (cr board) are found broken (i.E., physical damage).Event3: threads of k-connector found deformed.Due to that air gas leakage is coming from it.Event 4: internal tubes found deformed/cut.There was no patient involvement.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, and to correct information provided in the initial report.The device was returned to olympus for evaluation and the customer's allegations were confirmed.Based on the results of the investigation, phenomenon (1):¿equipment is not getting on¿ occurred due to damage of front panel and connector of main board; phenomenon (2): ¿gas leakage¿ occurred due to deformation of screw thread of k connector; phenomenon (3): ¿internal tubes found deformed/cut¿, root cause could not be determined from investigation result.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.Olympus will continue to monitor field performance for this 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 (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: 17425331
• MDR Text Key: 321327351
• Report Number: 3002808148-2023-07714
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 07/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• 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