MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DISTAL COVER

Model Number	MAJ-311
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction to h6.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, that the distal cover fell off after installation.This issue occurred after a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.The intended procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.It has been over 1 year since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be a temporary mistake made by the user when attaching immediately after opening the package, as indicated by the investigation result.The event can be prevented by following the instructions for use which state: operation manual 3.4 attaching accessories to the endoscope, attaching the distal cover 9.Confirm that the bottom end of the distal cover does not spread as shown by the arrows in figure 3.22, and that the white ring of the distal end is not covered by the distal cover as shown in figure 3.22.Stroke the distal cover with your fingers and pay attention that the distal cover is not put over the distal end as shown in figure 3.23.Otherwise, the distal cover may be damaged.When continuing the examination with the condition like mentioning above is confirmed, the distal cover may slip off the distal end during the examination.Replace the distal cover with a new one.Olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL COVER
• Common Device Name: DISTAL COVER
• 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: 19570759
• Report Number: 9610595-2024-12371
• Device Sequence Number: 6112849
• Product Code: FET
• UDI-Device Identifier: 04953170071393
• UDI-Public: 04953170071393
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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-311
• Device Lot Number: 35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 10/01/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/21/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: TJF-260V - DUODENOVIDEOSCOPE
• Patient Sex: Unknown