MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-AW

Device Problem Component Missing (2306)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the reported issue was confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, during reprocessing, the cleaning case rubber of the endoscope reprocessor was missing.Upon inspection of the customer¿s returned device it was observed, the sealing plug of the washing case was confirmed to be missing.This report is being submitted for the malfunction found during evaluation.There was no patient involvement in this event.

Manufacturer Narrative

This supplemental report is being submitted to correct the mdr aware date in section g3 from the initial mdr.The correct aware date should have been oct 30, 2023 and not sep 25, 2023.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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, the definitive root cause was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 18083717
• MDR Text Key: 327517637
• Report Number: 9610595-2023-16604
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/08/2023; 01/10/2024
• Supplement Dates FDA Received: 11/10/2023; 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GIF-H290, GASTROINTESTINAL VIDEOSCOPE.