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

Model Number UHI-4

Device Problem Mechanical Problem (1384)

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

Event Date 07/24/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus repair center.The inspection found the insufflation function failed, the internal dampers were damaged and therefore, the internal components could not be held firmly and the cocket of the circuit (cr) board was hit by internal components and got damaged.Additionally, the air feeing cannot be automatically stopped due to a defective cr board and the gas volume measure is not accurate due to a defective manifold unit.The device has not been repaired in the past year.The investigation is ongoing; therefore, the root cause of the reported phenomenon cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.

Event Description

Olympus (osh) was became aware that the in-house asset/loaner high flow insufflation unit¿s internal dampers were damaged, ¿anti-shock pad is damaged¿.The problem was found maintenance.There was no procedure or patient involvement.No death, injury or harm was reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 insufflation function failed because the internal dampers were damaged and therefore, the internal components could not be held firmly which caused damage to the socket of the circuit (cr) board.The root cause of the damaged inside damper was unable to be identified.In addition, it¿s likely the air feeding could not be automatically stopped due to a faulty circuit board (cr board).The root cause of the faulty circuit board was unable to be identified.Additionally, it¿s likely the gas volume measured was not accurate due to a faulty manifold unit.The root cause of the faulty manifold unit was unable to be identified.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 nishisgo-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: 15255664
• MDR Text Key: 305494990
• Report Number: 3002808148-2022-01181
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: 07/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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