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 07/02/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to omsc for evaluation.The root cause of the user¿s report cannot be conclusively determined but the most likely causes for the reported phenomenon (distal end cover falling off) are as follows: 1) distal cover was attached inappropriately.2) scope distal end had some abnormality such as adhesion of foreign material, breakage.3) scope distal end received greater stress during procedure such as frictional load by twisting / pushing / pulling scope in body than the pulling or twisting stress user applied to distal cover during inspection prior to use.The device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00014.

Event Description

It was reported by an olympus representative on behalf of a user facility that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the single use distal cover became detached from the evis exera iii duodenoscope.The cover fell off but was retrieved successfully by a roth net.The retrieval caused a surgical delay while the patient was under general anesthesia, but the time frame was not specified.The cap was on correctly, but it was stated that it may have gotten hooked on the trocar and over time slipped off.No irregularities were seen before attaching it to the scope.The physician did make sure the cover was securely on the scope by twisting or pulling to make sure it would not come off.No anti-fog agent was applied to the lens.The procedure was completed with the same devices.No patient harm was reported.This is related to patient identifier number (b)(6) which was reported under mfr.Report number 8010047-2021-09368.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the final investigation, it is likely that the distal cover endured greater stress during the procedure than the stress applied during the inspection of the device prior to use (pulling or twisting stress).This is evident because the trocar contacted the distal end of the subject scope.However, the root cause could not be identified.This supplemental report includes a correction to d4.Information has been added to d4 that was inadvertently not included on the initial medwatch.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: 16320150
• MDR Text Key: 309016490
• Report Number: 9610595-2023-01959
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAJ-2315: LOT UNKNOWN
• Patient Outcome(s): Required Intervention