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

Model Number	TJF-Q170V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer, during the endoscopic retrograde cholangiopancreatography (ercp), the single use distal cover fell off the duodenovideoscope inside the patient and migrated distally.The user performed forward-viewing endoscopy to retrieve the cap but could not find it.They tried to locate it by fluoroscopy but the cap was not radiopaque and there are no radiopaque markers on it.The patient was admitted, and the next morning the patient passed the cap in their stool which was retrieved and not damaged.Afterwards the customer did an experiment and kept the cap in the abdomen of another patient who was undergoing a computerized tomography (ct) scan and abdominal x-ray, and the cap was not visible on either ct scan nor the x-ray.The customer noted that the cap is for single use but they can be removed intact very easily, and in their country due to financial constraints, these caps are reused multiple times and is one of the main reasons for the dislodgement of the caps during the procedure.The distal cover in this procedure was a reused one.The caps are difficult to locate when they fall off inside the patient as they are not visible on x-rays or ct scans.No patient harm was reported.The customer did not apply anti-fog agent to the scope lens.There were no chemicals used during the procedure that could adhere to the tip of the scope or distal cover.There was no damage on the distal cover when attached to the scope.The customer did not pull and twist the distal cover to make sure it did not come off.Related patient identifiers: (b)(6) single use distal cover (maj-2315/ sn: (b)(6)).(b)(6) duodenovideoscope (tjf-q170v / sn: (b)(6)).This medwatch is for (b)(6).
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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, the reported event (distal cover detachment) occurred due to insufficient attachment to the scope.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: chapter 3 (section 3.5) - prevention and operation manual: chapter 4 (section 4.1) ¿ detection.This supplemental report includes a correction to e1 and g2 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18561772
• Report Number: 9610595-2024-01412
• Device Sequence Number: 14629518
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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-Q170V
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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: SINGLE USE DISTAL COVER (MAJ-2315/ SN: H2Y(B)(6.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male