MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE; FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE

Model Number TJF-Q190V

Device Problems Contamination (1120); Material Puncture/Hole (1504); Material Twisted/Bent (2981)

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

Event Date 10/28/2022

Event Type  malfunction  

Event Description

The customer reports a pancreatic plastic stent was lodged inside instrument channel of an evis exera iii duodenovideoscope and not removed until after this same product was used on multiple patients.Possible cross contamination.No hiv or hep c in any patients.No updates on any infection.Hospital has reported to their own infection control officers and monitoring patients involved.The customer asked for a full factory inspection especially manufacturer instrument channel guidance, if a stent could have found a cave inside the channel to hide.Cleaning brushes passed with no issues.Additional details regarding the reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical inspection of the returned device: the user's report is confirmed.Olympus found kinks and puncture inside the biopsy channel.Image ok during inspection, no fluid invasion inside scope.Labels: customer sticker-illegible.Forceps passage: kinks, debris and punctures.Low angulation.Control knob movement: play.Adhesive rubber glue cracked.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Multiple attempts were made to obtain additional information regarding the event however, were unsuccessful.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, a root cause could not be determined.A pancreatic plastic stent remained inside the biopsy channel for some cause.Since nonconformity to affect occurrence of the event was not confirmed with the subject device and additional information was not received from the user, the cause of the remained stent was difficult to presume.Since the user deviated from instructions for use (ifu) in reprocessing and/or inspection prior to use, the stent remained in the biopsy channel was not removed / detected.The following is included in the device ifu: ¿inspection of the endoscopic system: inspection of the instrument channel and forceps elevator: insert the endo therapy accessory through the biopsy valve.Confirm that the endo therapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope." "safety precautions: reprocess all channels of the endoscope, including the instrument channel, and all accessories after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators." "brush the endoscope¿s channels: follow the instructions in this chapter to ensure you thoroughly brush the inside of the instrument channel, the instrument channel port, the suction channel, and the suction cylinder of the endoscope.Insufficient brushing may pose an infection control risk.¿ "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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE
• 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: 15852181
• MDR Text Key: 307921322
• Report Number: 9610595-2022-04480
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• 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