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

Model Number TJF-Q290V

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

The customer reported the evis lucera elite duodenovideoscope was being used for a therapeutic and diagnostic procedure and the forceps elevator would not move down.No adverse effects to patient reported.

Manufacturer Narrative

The device was returned for evaluation.During examination, the reported issue was not confirmed.Examination identified the following issues: the bending section cover adhesive was chipped and scratched; the switch box 1 was scratched; the universal cord protector was scratched; and the connecting tube was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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, it is likely that the event occurred due to stress of repeated use, external factors, or handling of the device.The event can be prevented by following the instructions for use (ifu) which state: "chapter 3 preparation and inspection, section 3.3 inspection of the endoscope.[inspection of the forceps elevator mechanism] 1 straighten the bending section.2 move the elevator control lever slowly all the way in the opposite direction of the ¿u¿ direction.3 while observing the forceps elevator at the distal end of the insertion section, slowly move the elevator control lever in the ¿u¿ direction until the elevator control lever stops.Confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly.4 confirm that the forceps elevator remains stationary when pushed from behind while holding the elevator control lever stationary.5 move the elevator control lever slowly all the way in the opposite direction of the ¿u¿ direction.Confirm that the lever can be operated smoothly and that the forceps elevator lowers smoothly." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Updated: b5, g6, h2, h10.

Event Description

The customer provided a completed questionnaire about the reported event.The customer response stated there was no procedural information available, they could not confirm whether procedure was completed and they could not confirm whether delay occurred.The customer could not confirm whether there was any patient or procedure impact.In response to the request for the physician's opinion: "it's first time.But did it well." the customer could not confirm whether there were patient implant devices and could not confirm any details about other products in use at the time of event.In response to the request about the usage environment, the customer stated "the device was re-cleaned, but forceps elevator did not move." finally, the customer confirmed that these devices are inspected prior to use but could not confirm whether the forceps elevator function was included with that check.

• Brand Name: EVIS LUCERA ELITE 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: 17591666
• MDR Text Key: 321742686
• Report Number: 9610595-2023-11991
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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