MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT; LAPAROSCOPIC INSUFFLATOR

Model Number UHI-4

Device Problems Intermittent Continuity (1121); No Device Output (1435)

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

Event Type  malfunction  

Event Description

During an asset return inspection with no complaint from the customer, an error code e03 was observed on the device.There was no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

Device evaluation and inspection, service repair noted the following findings: error e03 observed intermittently likely due to faulty main board (printed circuit board failure).Additionally, housing inspection found scratches on top cover.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿ investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported e03 error code which indicates an abnormal pressure sensor.A review of the device history record (dhr) found no deviations that could have caused or contributed this issue.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because of the main internal circuit board was faulty.The root cause of the fault was unknown.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): AIZU 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: 15303703
• MDR Text Key: 305507489
• Report Number: 3002808148-2022-01439
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2012
• 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