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

Model Number UHI-4

Device Problems Circuit Failure (1089); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, error e03 and an intermittent power issue was observed.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, error e03 indicated a malfunctioning main board, and the intermittent power issue indicated a malfunctioning power cord.However, a definitive root cause of the reported issue could not be identified.According to the service manual, e03 indicates pipeline pressure sensor error, and its probable causes are connection failure of the connecting tube connected to the pipeline pressure sensor or faulty main board.Olympus will continue to monitor field performance for this device.

Event Description

A user facility returned the olympus asset, high flow insufflation unit, to the olympus service center.Upon inspection and testing of the returned device, error e03 was observed indicating a malfunctioning main board and an intermittent power issue was identified.This report is being submitted for the event found during evaluation.There was no patient involvement.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16417755
• MDR Text Key: 310350368
• Report Number: 3002808148-2023-01636
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 12/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• 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