MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GAS TUBE

Model Number MAJ-1741

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

The gas tube maj-1741 is planned to be returned to olympus but has not been returned yet.The user facility requested a component analysis of white foreign material.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 that the user found white residue remained in the gas tube maj-1741.The device was used for colonoscopy in combination with an olympus endoscopic co2 regulation unit ucr, and the procedure was completed.The user facility did not reprocess the gas tube after use because the tube is used for feeding co2 gas.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was evaluated at olympus medical systems corp.(omsc).As a result of the evaluation, the following was confirmed.-there was something like white powder on the exterior of the gas tube maj-1741.-when the gas tube maj-1741 was connected and operated according to the instruction manual, there was no abnormality.Foreign material remained inside the gas tube maj-1741 because the user had not reprocessed the gas tube.Due to not reprocessing, components derived from silicone oil, chemicals, cleaning liquid, etc.Remained inside the gas tube maj-1741.The exact cause of the intrusion of components derived from silicone oil, chemicals, cleaning liquid, etc.Into the gas tube could not be conclusively determined.The instruction manual states that the gas tube should be reprocessed before use and that insufficient reprocessing can infect the patient or operator.Therefore, it is possible that the user facility did not reprocess due to incorrect handling.Omsc was unable to review the device history record and the date of manufacture was unknown, because the serial number of the gas tube maj-1741 is unknown.If additional information becomes available, this report will be supplemented.

• Brand Name: GAS TUBE
• Type of Device: GAS TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12187665
• MDR Text Key: 264280747
• Report Number: 8010047-2021-09042
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1