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

Model Number TJF-Q190V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus the single use distal cover fell off from the evis exera iii duodenovideoscope during withdrawal of the scope at the end of an endoscopic retrograde cholangiopancreatography (ercp).The distal cover was not retrieved, and the patient was reportedly informed by the customer that the distal cover will pass.The ercp was technically difficult due to ampullary stenosis and haraldsson type 4 major papilla, but no maneuvers that could have been disrupting to the cap were done.The distal cap was also checked before use.There were no reports of patient harm.This event is reported under the following patient identifiers: (b)(6) - single use distal cover.(b)(6) - evis exera iii duodenovideoscope.

Event Description

The customer confirmed the procedure was therapeutic and it is unknown where in the patient the cap come off.The device came off at the end during withdrawal of the scope.The indication for the procedure was choledocholithiasis, and the patient had no relevant preexisting conditions.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and fdt additionally, to provide information received through follow up from the customer and an correction to the initial (e1, e2, and e3).The customer confirmed no anti-fog agent was used on the scope lens and boson scientific endoglide water soluble lubrication was applied.After attaching the distal cover to the scope, the user did confirm that the cover was not damaged.The user did attach the distal cover to the scope and then pull or twist the cover to make sure it does not come off.The customer also believes the distal cover was pushed firmly until the hook shown in the attached image of the distal ring were fully visible within the distal cover opening.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 possible that the distal cover did not completely go over hook at the distal end, which is insufficient attachment to the device.It made the cover easy to come off the device.However, the root cause of the phenomenon could not be specified.The event can be detected and 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
• Type of Device: 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: 16921017
• MDR Text Key: 315115073
• Report Number: 9610595-2023-07412
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BOSON SCIENTIFIC ENDOGLIDE.; MAJ-2315 SINGLE USE DISTAL COVER.
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic