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

Model Number TJF-160R

Device Problems Contamination (1120); Material Twisted/Bent (2981); Failure to Clean Adequately (4048)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned, and an evaluation completed for it.Upon inspection and testing, it was observed that that the forceps elevator wire (k-wire) was cut with a bent part.In addition, the distal end had presence of an unidentified brown foreign material.This is attributed to insufficient cleaning.Other observation for the device: due to a pinhole on distal end rubber coating (a-rubber), water tightness is lost; adhesive on a-rubber is detached; connecting tube has coating peeling and buckling; universal cord has buckling; due to wear of angle wire, bending angle in up direction does not meet the standard value; due to wear of angle wire, the play of up/down and right/left knob is out of the standard value; and connecting tube, control unit, and universal cord have a scratch.The user¿s complaint of low angulation was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The customer returned the device for evaluation and repair, after reprocessing, for the issue of low angulation in up/down knob as observed during maintenance.The device had no leakage, image was okay, and no other issue was observed.There is no patient involvement and no reported harm to the patient.Upon evaluation of the returned device, it was observed that the forceps elevator wire (k-wire) was cut with a bent part.In addition, the distal end had presence of an unidentified brown foreign material.This is attributed to insufficient cleaning.This medwatch is being submitted for the reportable issue of presence of foreign material on the distal end and the bent k-wire as observed during device evaluation.

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 of the reported event is unable to be determined.However, the cause of the event is likely due to the user not being more likely to perform manual cleaning properly.Additionally, we presume that the strands were snapped due to fatigue fracture from repeated manipulation of forceps elevator.The event can be detected and prevented by following the instructions for use (ifu) which state: ¿ifu: operation manual, inspection of the forceps elevator mechanism- perform the following inspections while the bending section is straight.Inspection for smooth operation.While observing the forceps elevator at the distal end of the endoscope, slowly move the elevator control lever all the way in the ¿u¿ direction.Confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly.Hold the elevator control lever and confirm that the forceps elevator remains stationary while pushed from behind.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.¿.Ifu: operation manual warns on the event as follows: important information ¿ please read before use- using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and infection.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: 16059080
• MDR Text Key: 308257341
• Report Number: 9610595-2022-06167
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K980465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2003
• 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