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

Model Number UHI-4

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.Therefore, olympus could not investigate the subject device.However, the field service engineer checked the subject device at the user facility and found the followings; it was confirmed the reported phenomenon.It was found the co2 gas flow was too slow to reach the set value and take long time.It was found all front panel buttons and led indicators were working fine.It was found the gas pipe, regulator and hose pipe conditions were in good condition.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 from the user via the field service engineer of (b)(4) that it was found the co2 gas output flow and cavity pressure of the subject device were insufficient as the set value, hence the cavity pressure was not maintained due to the subject device malfunction during the laparoscopic cholecystectomy procedure.The intended procedure was completed with the same set of equipment.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was inspected at olympus india as per standard guidelines but did not find low pressure (insufficient pressure) or any other functional issue.Hence the subject device was working ok.Moreover, the subject device was kept under observation for four working days but did not find any functional issue.For low-pressure issues, it was recommended that the subject device should receive sufficient gas input.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root cause of the reported phenomenon could not be identified.[consideration] from the following facts, the cause of the reported phenomenon could not be identified.In addition, it could not be determined the cause because it could not confirm the abnormality of the subject device by inspection of olympus india and did not return the subject device to the manufacturing site.Facts confirmed from the investigation.-from the information of the inspection, it was confirmed that there was no abnormality.-the subject device was not returned to the manufacturing site.If additional information becomes available, this report will be supplemented.

• 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: 12825929
• MDR Text Key: 280900628
• Report Number: 8010047-2021-14658
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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: 12/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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