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

Model Number TJF-260V

Device Problems Material Frayed (1262); Peeled/Delaminated (1454)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the reported issue (broken wire) was confirmed.It was observed the forceps elevator wire was frayed due to external factors.In addition, service found there was a leakage due to holes in the insertion tube, the right left axis screw of the control section was loose, there was dirt on the control section that was difficult to remove, the adhesive on the bending section cover was cracked, there was flare due to a crack on the objective lens, and there was water coverage on the electrical connector.Scratches were observed on the control section, the tip cover, the switch box, the up/down knob, the up down angle fixing lever, the right/left knob, the right left angle fixing knob, the tip body, the control section cover, the grip, the universal cord, and the scope connector due to external factors.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the wire of the subject device was broken.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the adhesive part of the lighting lens was peeled off, and the forceps elevator wire was frayed.This report is being submitted for the malfunctions found during device evaluation (adhesive peeling off and frayed forceps elevator wire).Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the correction to b3 and the update to b5 of the initial medwatch.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 reported event is unable to be determined.However, the cause of the event is likely due to stress of repeated use, external factors, or handling caused the defect.Olympus will continue to monitor field performance for this device.

Event Description

The customer later confirmed the broken wire was observed during preparation for usage when attaching the distal cover.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15452066
• MDR Text Key: 306272077
• Report Number: 9610595-2022-01964
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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: 08/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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