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

Model Number TJF-260V

Device Problems Contamination (1120); Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the reported issue (broken k-wire) was confirmed.It was observed the k-wire was frayed and raised due to external factors.In addition, service found there was a leakage due a pinhole on the forceps channel, the bending angle was out of specification due to wear of the angulation wire, the insertion tube was wrinkled, the air/water supply cap was loose, the control unit body was scraped, the switch button #1 was worn, and the paint on the suction cylinder was peeled.The adhesive on the bending section cover was cloudy, chipped and cracked.Scratches were observed on the insertion tube, the lighting lens, the objective lens, the switch button #1, and the scope connector side of the universal cord 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 forceps elevator wire (k-wire) was broken.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the inside of the lighting lens was dirty due to the adhesive part peeling off the lighting lens and the forceps elevator wire was frayed and raised.This report is being submitted for the malfunctions found during device evaluation (dirty lighting lens and forceps elevator wire frayed and raised).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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Approximately 4 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that the reported phenomenon occurred due to the stress of repeated use, external factors, or handling.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15494885
• MDR Text Key: 303300763
• Report Number: 9610595-2022-02301
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 08/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• 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