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

Model Number JF-260V

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was confirmed.It was noted that there was waterproof failure due to a cut on the bending section rubber and there was a white scratch on the image due to a broken charge coupled device unit.The light guide lens was broken and the electrical connector was corroded.The forceps raising angle was out of standard due to loose forceps elevator wire.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported to olympus field service engineer, that the evis lucera duodenovideoscope had raised forceps elevator wires due to a cut/fray.The issue was found during reprocessing.There were no reports of patient harm associated with this event.

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 raised forceps elevator wires due to a cut/fray was that the k-wire had accumulated fatigue and was broken by repeated manipulation of the forceps elevator.The event can be detected/prevented by following the instructions for use which state: ¿3.2 inspection of the endoscope: inspection of the forceps elevator mechanism: inspection for smooth operation: visually confirm that the portion of the elevator wire extending from the distal end of the endoscope is not broken, frayed, or bent (see figure 3.5).If any damage (broken, frayed, or bent portion) is observed on the elevator wire as shown in figure 3.5, do not use the endoscope.¿ 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: 17553693
• MDR Text Key: 321725941
• Report Number: 9610595-2023-11722
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 07/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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