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

Model Number UHI-3

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus (b)(4), it was found that there were the foreign matters inside of the insufflation tube of the subject device.The subject device had been returned to olympus (b)(4) for repair of the irregular co2 gas inflow.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to olympus (b)(4) but has not been returned to omsc.Olympus (b)(4) checked the subject device for evaluation.It was confirmed that there were the foreign matters which were like fine particles inside of the insufflation tube of the subject device.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not confirm the manufacturing history (dhr)of the subject device, because its dhr has already passed the storage period.The root cause of the reported phenomenon could not be determined.[considerations] the following was confirmed from the investigation.-there was no abnormality other than the reported phenomenon inside the subject device at the inspection of olympus (b)(4).-the subject device was not returned to the manufacturing site.From the above investigation, the cause of the reported phenomenon could not be identified.In addition, it could not surmise the cause because it could not be obtained information on other the subject device abnormalities.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: 12833351
• MDR Text Key: 281335583
• Report Number: 8010047-2021-14720
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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 Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1