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

Model Number UHI-3

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was inspected by the repair center engineer, and the cr board was found defective, resulting in the failure of the air supply button.The customer's reported pressure setting value cannot be reached normally could not be reproduced.A review of the repair history shows the concerned product has no previous repair records.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

Olympus (osh) was informed that the customer high flow insufflation unit's "flow is slow during use and cannot reach normal pressure".The event occurred during preparation for use (patient was not under anesthesia) of a laparoscopic procedure.The intended procedure was not delayed more than 15 minutes and the procedure was completed using the same unit.No death or injury was reported to olympus.

Manufacturer Narrative

Correction: d5, e1, g2.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 16 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of the "insufflation button on the front panel cannot be operated", occurred because the main board was defective.This was based upon facts acquired from this investigation and the results of evaluation.However, the cause of this defect could not be further determined.The suggested phenomenon of "when the flow rate is set to 'medium', flow rate was lower and does not reach the set value" was not duplicated during inspection of the device.No further cause of this phenomenon could be determined.The suggested phenomenon of "abdominal cavity pressure does not reach the set value" was not duplicated during inspection of the device.No further cause of this phenomenon could be determined.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): 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: 13420033
• MDR Text Key: 295785085
• Report Number: 8010047-2022-02261
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K014166
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2005
• 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