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

Model Number UHI-4

Device Problems Corroded (1131); Electrical /Electronic Property Problem (1198)

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

Event Date 01/10/2022

Event Type  Injury  

Event Description

The customer reports during a laparoscopic cholecystectomy using a high flow insufflation device, the device goes into e03 error code and repeatedly turns off.The procedure was completed by changing to an open approach.No additional consequences to the patient were reported.

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of suspect device: e03-excessive pressure when inflated-pressure sensor abnormality.Cause: failure of motherboard board.The device goes into error mode and beeps.E03 is in the error memory.The motherboard needs to be replaced.The chassis and case cover are oxidized and need to be replaced.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the suspect device was reviewed.It was confirmed, the device was shipped in accordance with the specifications.The root cause of the reported event could not be identified.The following was confirmed in the provided information.·e03- excessive pressure when inflated-pressure sensor abnormality.Cause: failure of cr board.·the device goes into error mode and beeps.E03 is in the error memory.·the motherboard needs to be replaced.The chassis and case cover are oxidized and need to be replaced.

• 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: 13694936
• MDR Text Key: 291596774
• Report Number: 8010047-2022-04102
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• 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: 02/06/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other; Required Intervention