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

Model Number UHI-4

Device Problem Improper Flow or Infusion (2954)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to local service department of olympus.Local service department checked the subject device and found that the actual flow rate of the gas did not reach the maximum even when the flow rate was turned to the maximum.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user facility that during the surgery, the flow rate only reached 23l/min although 40l/min was set.The user finished the case with the subject device.There was no report of patient injury associated with the event.The subject device was used in combination with otv-s400 and clv-s400.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to local service department of olympus.Local service department checked the subject device and found that the reported phenomenon could not be confirmed.There was no abnormality in the device.The device evaluation result reported in initial mdr was corrected.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.The cause of the phenomenon could not be identified because no irregularity was found in the inspection of the device.Omsc presumed that the phenomenon was caused by some other factors such as connected devices, connection conditions, and patient¿s condition.

• 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
• MDR Report Key: 12538515
• MDR Text Key: 273552498
• Report Number: 8010047-2021-12363
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1