MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MOUTHPIECE

Model Number MAJ-674

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) investigated the subject device and confirmed the reported phenomenon.A analysis revealed that the main component of the brown spots was the potassium salt of carbonic acid.Omsc surmised that foreign material might come from cleaning agents and chemicals.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Event Description

The device got brown spots on the surface after autoclave reprocessing cycle olympus ultrasonic cleaner endosonic and alcohol wiping could remove the stains, but the stains appeared again after another autoclave reprocessing cycle.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

• Brand Name: MOUTHPIECE
• Type of Device: MOUTHPIECE
• 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: 10342505
• MDR Text Key: 202363951
• Report Number: 8010047-2020-04991
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-674
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• 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