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

Model Number JF-260V

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Event Description

A customer reported that the evis lucera duodenovideoscope forceps raising wire was elongated and cut.There were no reports of patient or user harm.The subject device was received at an olympus service center for evaluation.During inspection and testing, foreign material was observed in the nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

During the device evaluation, the nozzle was observed to be deformed.Due to wear of angle wire, the bending angle in up direction did not meet the standard value.Due to wear of angle wire, the play of up/down knob was out of the standard value.The adhesive on the bending cover (a-rubber) was peeling and chipped.The connecting tube, camera cover (c-cover), and distal end were scratched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 16 years since the subject device was manufactured.Based on the results of the investigation, the customer¿s reported issue could not be confirmed.The foreign material could not be identified, but there is a possibility that the foreign matter remained due to physical damage to the nozzle and deviation of the reprocess from the instruction manual.The event can be detected/prevented by following the instructions: the inspection method for the event is described as follows in the instruction manual (operation edition) "chapter 3 preparation and inspection 3.2 inspection of the endoscope and 3.6 inspection of the combination function with related equipment".[endoscope inspection] 8.Visually check that there are no abnormalities such as abnormal protrusion, dents, deformation, etc.In the air and water feed nozzles at the tip of the endoscope.[inspection of the cleaning function of the objective lens surface] 1.When the button is pressed while blocking the hole of the air and water supply button with your finger, check that water flows throughout the endoscope image.Olympus will continue to monitor field performance for this device.

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.Based on the results of the investigation, the definitive root cause of the foreign material could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 16956741
• MDR Text Key: 315915849
• Report Number: 9610595-2023-07658
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2006
• 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