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

Model Number	TJF-Q190V
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/26/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that during insertion of the duodeno videoscope into the patient's esophagus in a therapeutic endoscopic retrograde cholangiopancreatography procedure, a significant bleed to the left side of the esophagus was noted.The duodenoscope was withdrawn and a second scope was inserted to establish the nature and extent of the bleed.The tear was considered too large for repair.The case was discontinued, and the patient was sent for a ct scan.The ct scan showed active contrast leaking from the left side of the oesophagus into the chest, where upon a chest drain was inserted into the patient's left side.The surgeon counselled the patient and patient's family that to repair the tear would require a thoracotomy.The patient and patient's family declined the procedure, and the patient has now been placed in palliative care.The surgeon has commented that he believed the instrument elevator was not flat enough during instrument insertion which caused the tear to the patient's oesophagus.The device was inspected prior to use.
Additional Manufacturer Narrative
The evaluation of the device is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer.
Event or Problem Description
It was additionally reported that the patient has passed away in palliative care possibly 3 days post operation.There was no coronial inquest that the customer was aware of, and there was no autopsy conducted.The supervising surgeon and trainee fellow who conducted the operation have stated in the user facility's incident management report that they believe the instrument elevator on the subject device does not lie flat enough.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to field h3.The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported event.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, olympus confirmed that the elevator was parallel when forceps elevation lever was returned to the certain degree.Therefore, it is likely that the forceps elevator was not a direct factor in the esophageal injury which led to the patient's death.The root cause of the reported event could not be determined.The event can be detected by following the instructions for use which state: inspection of the endoscope; insertion.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Health effect - clinical code 4581 is used to code for mediastinitis and pleurisy.The report is being supplemented to provide additional information received as reflected in b5, b7, and h6.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient had various illnesses.When the patient was brought to the intensive care unit, the whole stomach was upside down or twisted, which made it difficult to get the scope in.The esophageal perforation occurred in the patient during active treatment.It was further noted that it was very difficult to get the scope into the patient due to the position of the hernia, so the surgical trainee retreated to the esophagus before returning to the stomach.After the perforation was identified, the procedure was stopped.The patient¿s family decided not to proceed with further treatment and the patient was placed into palliative care.Reportedly, it was unclear what exactly happened; however, the elevator arm may have been unconsciously poked up, or the cap (cap being a new cap) may not have been sitting straight.It was additionally reported that the procedure was being done for cholangitis.The esophageal laceration occurred in the middle section.The surgeon indicated that the elevator was likely raised during the maneuvering of the scope in the patient and confirmed that the cap was still on when the scope was withdrawn.The surgeon noted that the trainee may have mistakenly operated the elevator as the wheels are placed next to each other.The surgeon also commented that a function to lock/unable the forceps lever would be helpful to prevent the elevator arm from accidentally coming up.The surgeon believed that the direct cause of death was likely to be the esophageal perforation being left untreated and that infection was unlikely to be the direct cause in this case.The patient may also have had lung cancer which was not known prior to the procedure.Heavily high fever and multiple stones were also observed.The surgeon noted that the patient had presented to the hospital with a high fever and had been on antibiotics for 2 days.The surgeon could not remember the stone size.The surgeon further believed that the luminal contents may have perforated the mediastinum (mediastinitis) or the left pleural cavity (pleurisy).As for alternative treatment, the surgeon noted that under normal circumstances, physicians would consider treating esophageal hiatal hernia first as a priority before performing endoscopic therapy, but this option was not possible due to the patient's advanced age and various other illnesses/conditions the patient had.
Additional Manufacturer Narrative
This report is being supplemented to provide correction to h1 for information inadvertently left out in the first supplemental mdr.

• 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: 20241073
• Report Number: 9610595-2024-18564
• Device Sequence Number: 8741969
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/16/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 10/23/2024; 02/20/2025; 05/16/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/24/2024; 11/06/2024; 02/26/2025; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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.
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Death
• Patient Age: 89 YR
• Patient Sex: Female