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

Model Number MAJ-1742

Device Problems Device Reprocessing Problem (1091); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.The reported phenomenon was occurred due to the user handling.The reprocess procedure is described in the instruction manual.

Event Description

Olympus medical systems corp.(omsc) was informed that the user autoclaved the device without cleaning step.Other detailed information was not provided.There was no report of patient injury associated with the event.

• Brand Name: LOW FLOW 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11248885
• MDR Text Key: 233751400
• Report Number: 8010047-2021-01989
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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