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

Model Number TJF-Q190V

Device Problem Partial Blockage (1065)

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

Event Date 07/01/2022

Event Type  malfunction  

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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user attempted to remove the stent through the biopsy channel, by deviating from the instructions for use (ifu).Therefore, the stent was caught in the channel, causing the reported event.However, the root cause could not be determined.The event can be detected/prevented by following the ifu which state: ¿precautions: do not retrieve the stent through the instrument channel of the endoscope.A stent or piece(s) of a stent may stay in the instrument channel or the suction channel of the endoscope even after reprocessing.It may cause incomplete reprocessing, and pose an infection control risk, cause equipment damage, or reduce performance.¿ in addition, the following non-reportable malfunctions were found during the device evaluation that were not reported on the initial medwatch: bending angle does not meet specification.Angle knobs not locking correctly.Plastic distal end cover (c-cover) is scratched or dented.Bending section cover (a-rubber) adhesive is detached, chipped, cracked, or has a burr insertion tube has scratches.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the suspect device: the user's report is confirmed.Unable to pass a brush through the instrument channel due to blockage.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, a stent became lodged in the working channel approximately 20cm from the distal tip.This was noticed when the user was grasping the stent with a snare and removing the scope.The procedure was completed with another scope.There was no adverse effect to the patient as a result of this occurrence.

• Brand Name: EVIS EXERA III 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: 15277843
• MDR Text Key: 303298114
• Report Number: 9610595-2022-01219
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2020
• 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
• Treatment: SNARE (MODEL/LOT UNK)