MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WASHING CASE

Model Number	MAJ-827
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus, and it is not expected to be returned for evaluation of the reported issue.However, a field service engineer(fse) visited the site and confirmed the reported event.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the washing case's rubber was missing during reprocessing; there was no patient under anesthesia at the time.There was no procedure involved, and therefore no report of delay or patient harm.This report is linked to the patient identifier, (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information, based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device, since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was evaluated onsite by an olympus field service engineer and the customer's allegation was confirmed.The device was not returned to olympus for physical evaluation.Based on the results of the investigation, it is likely, that while the user was handling the washing case.The chain of the rubber button was pulled unintentionally and the rubber detached from the lid and the chain.However, a definitive root cause could not be established.Olympus will continue to monitor field performance for this device.

• Brand Name: WASHING CASE
• Common Device Name: WASHING CASE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18238181
• Report Number: 9610595-2023-18400
• Device Sequence Number: 3176882
• Product Code: FEB
• UDI-Device Identifier: 04953170069512
• UDI-Public: 04953170069512
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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-827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290-EVIS LUCERA ELITE GI VIDEOSCOPE
• Patient Sex: Unknown