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

Model Number TJF-260V

Device Problems Material Twisted/Bent (2981); Unexpected Color (4055)

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

Event Type  malfunction  

Manufacturer Narrative

This device is not sold in the u.S., but a similar device is.The device is returned, and an evaluation completed for it.Upon inspection and testing, it was observed that the inside of the light guide (lg) lens had color change.This is attributed to a gap in the adhesive, caused by stress, through which impurities can enter the inside of the lens.In addition, the forceps elevator wire has damaged with raised wire.This is attributed to mechanical or chemical stress applied by repeated use over a long period of time.Other observations for the device: angulation in the up direction is out of standards due to worn angle-wire; screen is partly dark due to scratch of charge couple device (ccd) lens; crease at the ccd lens; lg lens is broken; adhesive of distal end rubber coating (a-rubber) is broken; crumple at the connecting tube; suction cylinder is cut off; crumple at the universal cord; electrical connector is corroded; and scope cover is polluted.The user's complaint of the upward angulation was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for evaluation and repair of the forceps elevator skipping and not having a smooth upward movement occurring during preparation for use.There is no patient involvement and no harm to any patient.The intended diagnostic procedure was completed without any problem or delay with another similar device.Upon evaluation of the returned device, it was observed that the inside of the light guide (lg) lens had color change.This is attributed to a gap in the adhesive, caused by stress, through which impurities can enter the inside of the lens.In addition, the forceps elevator wire has damaged with raised wire.This is attributed to mechanical or chemical stress applied by repeated use over a long period of time.This medwatch is being submitted for the reportable issue of lg lens color change on the inside and raised wire of the forceps elevator as observed during device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the dirty lens was, the lg-lens glue had peeled by physical stress to the distal end or chemical stress due to chemical solutions used.Then humidity entered the lg-lens and caused corrosion.K-wire became snapped due to fatigue breakdown from repeated operation of the forceps elevator, then the k-wire became raised resulting from repeated reprocessing around the forceps elevator or attachment/detachment of distal cover 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: 16491706
• MDR Text Key: 311382411
• Report Number: 9610595-2023-03809
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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