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

Model Number UHI-4

Device Problems Device Reprocessing Problem (1091); Corroded (1131); Pressure Problem (3012); Unexpected Shutdown (4019)

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

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the alarm sound is generated, and the front panel is turned off on the high flow insufflation unit.The issue was found during preparation for use.There were no reports of patient involvement.

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.The device was inspected, and a failed pressure sensor error (#03 in logs) was observed.Based on the results of the investigation, it is likely that the phenomena occurred due to the failure of the pressure sensor.However, a specific cause of the faulty pressure sensor could not be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional findings from the device evaluation and updated legal manufacturer's final investigation.A visual inspection was performed on the device and scratches on the top cover and rust on the rear panel close to inlet area were found.The top cover was removed to inspect the interior and found an unknown liquid coming out from the connector unit.There were rust spots on the inside rear panel, and rust on the nut of 1st regulator unit where the s shape pipe inserted to.The device was then powered on and all leds on front panel were flashing once, then went off, leaving only cavity mode leds run toggle between normal and small.Once the cavity mode selector was pressed, the alarm would sound continually.The error log was checked and found e03 on the error log#1 and 003 on log #4.The error e03 indicates irregularity with the channel pressure sensor.Additional reportable malfunctions were identified during the device the evaluation, which were the following: unknown liquid coming out from the connector unit, rust on the nut of 1st regulator unit where the s shape pipe inserted to and the flashing leds.The investigation determined it was likely that the unknown liquid was left over from the cleaning solution used in the reprocessing process, the rust was caused by moisture or humidity inside the regulator unit and cause of the flashing leds could not be identified.The investigation determined the likely cause of the device turning off and beeping continuously at the moment of selecting the cavity mode was due to a failure of the cr board (pressure sensor/pressure sensor circuit).Olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16014381
• MDR Text Key: 308155755
• Report Number: 3002808148-2022-05417
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/20/2023; 03/17/2023
• Supplement Dates FDA Received: 02/08/2023; 04/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2017
• 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