MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the returned device, the customer¿s report was confirmed.The evaluation found fluid inside the tubes, manifold unit, electropneumatic proportional valve, k-connector and first regulator unit.Additionally, the light-emitting diode (led) indicator for the flow rate of the front panel worked intermittently and the rear panel was rusty.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer reported to olympus, the uhi-4, high flow insufflation unit, unknown liquid was found inside the pneumatic system tubes.The intended therapeutic procedure was completed using the same device.No other equipment was replaced during the procedure.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and the device history record (dhr) review.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause could not be conclusively specified.The investigation determined the most likely cause of the fluid intrusion into the tubing was a result of handling of the device.The investigation also determined that the cause of the chip in the light-emitting diode (led) display of the bar graph was most likely caused by a component failure.The led element mounted on the front panel has failed.Follow up with the user facility is currently being performed.A supplemental report will be submitted if any additional information is provided by the user facility.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This supplemental report is submitted to provide additional information from the reporter.

Event Description

Additional information was provided by the reporter.The event was noted to have occurred at the beginning of the procedure.The procedure was completed using a different laparoscopic tower.There was a delay in the procedure but the length of the delay is unknown and the patient was not under general at the time of the delay.There were no abnormalities noted during the inspection of the device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12246049
• MDR Text Key: 270065681
• Report Number: 8010047-2021-09520
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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
• Treatment: CAMERA CONTROL UNIT OTV-S400 (B)(6).; CAMERA HEAD CH-S400-XZ-EA (B)(6); CO2 INFLATOR UHI-4 (B)(6).; DIGITAL RECORDER HVO-3300MT (B)(6).; LENS 0 ° 10MM WA4KL100 (B)(6).; LENS 30 ° 10MM WA4KL130 (B)(6).; LIGHT GUIDE (B)(6).; LIGHT SOURCE CLV-S400 (B)(6).; MONITOR LMD-X310MT (B)(6).; SYSTEM TROLLEY TC-E400 (B)(6).; TRANSPORTATION TROLLEY WM-NP2 (B)(6).; UNIT OF ELECTROSURGERY WITH PEDAL ESG-400 (B)(6).; UPS NEO-2000LV (B)(6).