MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. WATER CONTAINER (LID); CAP

Model Number	MAJ-1025
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while reprocessing his olympus water container lid the surface of the white caps on the water and gas bottles had melted.There was no patient involvement during this event.
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user's report was confirmed.There was a physical abnormality in the appearance of the cap.The unit could not be tested due to the sustained damage.If additional information becomes available following the device evaluation, a supplemental report will be filed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured in august 2015, though a specific date was not identified, it has been over 7 years since the device was manufactured.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to inappropriate and/or insufficient reprocessing.The event can be prevented by following the instructions for use (ifu) which state: chapter 5, ¿reprocessing¿ and chapter 6, ¿storage¿.¿improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance." if additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER CONTAINER (LID)
• Common Device Name: CAP
• 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: 14653309
• Report Number: 8010047-2022-09809
• Device Sequence Number: 4867797
• Product Code: FET
• UDI-Device Identifier: 04953170079252
• UDI-Public: 04953170079252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-1025
• Device Lot Number: 58R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown