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

Model Number MAJ-1741

Device Problem Device Reprocessing Problem (1091)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to any of olympus locations.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined.However, based upon the reported information, there was the possibility that this event was attributed to the use of the subject device without checking the instructions of the reprocess in the instruction manual.Therefore omsc concluded that there was no failure of the subject device, it was due to the user's handling.The instruction manual of the ucr which is used conjunction with the subject device states the appropriately reprocessing methods of the subject device.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that the subject device had never been reprocessed.There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11750923
• MDR Text Key: 250426481
• Report Number: 8010047-2021-05633
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1741
• Device Lot Number: 7837487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1