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

Model Number	MAJ-311
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier:(b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at the end of therapeutic, endoscopic retrograde cholangiopancreatography (ercp) stent exchange procedure, the distal cover fell out into the patient¿s esophagus while the duodenovideoscope was being pulled out of the body.The distal cover was retrieved with the aid of grasping forceps.The procedure was completed with the same device.There was no mucosal damage, and no harm to the patient.The cover was disposed of by the facility.The device was inspected prior to use but the inspection may have been incomplete.An olympus representative subsequently explained the correct installation and inspection method to the staff.
Additional Manufacturer Narrative
This report is being supplemented 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 lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the distal cover was insufficiently attached and therefore easily detached from the scope when a load was added during use.Since the subject device was not returned to olympus for evaluation, the root cause could not be determined.This supplemental report includes additional information received from the customer.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that there was no delay in the procedure, as the issue occurred while the scope was being removed from the patient at the end of the case.The patient did not experience any complications due to the incident.The patient¿s current condition is unknown.

• 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: 19954493
• Report Number: 9610595-2024-16013
• Device Sequence Number: 21057414
• Product Code: FET
• UDI-Device Identifier: 04953170071393
• UDI-Public: 04953170071393
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-260V/2613349
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown