MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
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	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device referenced in this report has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
The customer reported to olympus that the single use distal cover came off in the patient's mouth as the evis exera iii duodenovideoscope was taken out during a therapeutic endoscopic retrograde cholangiopancreatography (ercp).The patient swallowed the cover and it became lodged in the esophagus.The cover was then retrieved with grasping forceps.The procedure was delayed by 20 minutes and completed with the same set of equipment.The patient is otherwise well and had a normal recovery.The device was inspected prior to use.The related patient identifier (b)(6) reports the single use distal cover.
Additional 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 the suggested event may have been caused by the following.-the distal cover was damaged by chemical attack due to adhesion of chemicals such as anti-fog agent to the cover, which made the cover easy to come off the subject device.-the distal cover was insufficiently attached to the subject device, which made the cover easy to come off the subject device.However, the root cause of the suggested event could not be specified.The event can be detected and/or prevented by following the instructions for use which state: "detection method is described in 4.1 of chapter 4 in operation manual.Preventive measure is described in 3.5 of chapter 3 in operation manual." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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: 18369343
• Report Number: 9610595-2023-20023
• Device Sequence Number: 11895297
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K220587
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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: MAJ-2315/UNKNOWN LOT NO.; STANDARD KIT SETUP FOR ERCP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown