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

Model Number TJF-160VR

Device Problem Material Frayed (1262)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

The customer reported there were defects at the distal end cover and forceps elevator of the subject device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found the forceps elevator wire was frayed.This report is being submitted for the malfunction found during evaluation (frayed elevator wire).There was no harm or user injury reported due to the event.

Manufacturer Narrative

During inspection and testing, service found the forceps elevator wire was frayed.The forceps elevator could be raised and returned to the neutral position; therefore, the reported issue was not confirmed.In addition, the adhesive on the bending section cover was separated, the nozzle was slightly deformed, and the image shown on the monitor screen was slightly grainy.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Additional information obtained from the customer stated the defects at the distal end cover and forceps elevator of the subject device were found following an endoscopic retrograde cholangiopancreatography.The procedure had already been completed with the subject device and there was no effect on the patient due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information that was received from the user facility regarding the reported issue.

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 root cause could not be determined.It is likely the forceps elevator wire snapped due to fatigue from repeated operation.The user then kept using the device, not noticing the wire had snapped, and the snapped wire got caught in the distal cover when it was attached or came into contact with the cleaning brush and got bent.The event can be detected by following the instructions for use (ifu) 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 EXERA 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: 16010351
• MDR Text Key: 307901957
• Report Number: 9610595-2022-05711
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024033
• 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,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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