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	04/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device 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.This report has also been submitted on importer medwatch report #2429304 - 2023 - 00163.
Event or Problem Description
The customer reported to olympus that the single use distal cover fell off from the evis exera iii duodenovideoscope during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.An esophagogastroduodenoscopy (egd) was performed to see if the distal cover was retained in the patient's gastrointestinal tract.After both the ercp and egd were completed, the distal cover was found in the patient's mouth.The procedure was prolonged by 5 minutes with the patient under anesthesia.The distal cover was disposed after the procedure.The operator felt that the distal cover had been placed correctly without resistance or difficulty and that he felt the cover "snap" into place.The operator further felt that there were no errors in placing the device.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6)- evis exera iii duodenovideoscope.(b)(6)- 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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the cover easily came off the subject scope due to insufficient attachment (refer to capa-200735).However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: ¿operation manual includes the detection way at chapter 4 - 4.1.¿ ¿operation manual includes the preventive measures at chapter 3 - 3.5.¿ this supplemental report includes information added to d8.Also, a correction has been made to e4.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: 17054270
• Report Number: 9610595-2023-08342
• Device Sequence Number: 16975553
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 05/04/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 / LOT NUMBER H2713.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown