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

Model Number TJF-Q190V

Device Problem Material Frayed (1262)

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

Event Date 08/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the forceps raiser was defective.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera iii duodenovideoscope had a boston scientific hydratome tip used, the user noticed that the tip was frayed from the tip of the scope.The issue was found during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the procedure was completed with the same device, and it was reported that the procedure took slightly longer (the timeframe was not specified).There were no reports of patient harm and the issue did not result in negative effects for the patient.Related patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer: updated field: a2 / a3 / a4 / a6 / b5 / b7.

Event Description

The device was inspected prior to use, the issue was found during the middle of a therapeutic procedure, there was a slight delay (the timeframe was no specified) the delay did not result in a negative effect for the patient, and the patient was under moderate sedation (cat 2) with propofol.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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 reportable malfunction was not identified and therefore the root cause of the suggested event could not be determined.The event can be prevented by following the instructions for use which state: ¿ while raising the forceps elevator, do not insert or withdraw the endotherapy accessory with excessive force, open or close the distal end of the endotherapy accessory, or extend the needle of the instrument.This could damage the instrument channel and/or the endotherapy accessory and could cause patient injury, bleeding, and/or perforation.If the endotherapy accessory cannot be inserted or withdrawn, the distal end of the endotherapy accessory cannot be opened or closed, or the needle of the instrument cannot be extended, move the elevator control lever in the opposite direction of the ¿ u¿ direction to lower the forceps elevator.¿ operation manual 5.1 troubleshooting - chapter 5 troubleshooting olympus will continue to monitor field performance for this device.

Event Description

The customer confirmed the scoop is always tested in advance for rinsing, watering and extraction.The reported problem did not affect the diagnostic or therapeutic outcome of the procedure.The patient was discharged as planned and the patient's current health is good.The hospital stay was not extended due to the device malfunction or prolonged procedure.No medical intervention (i.E.Treatment outside the scope of the procedure) required as a result of the reported problem.

• 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 (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: 17712714
• MDR Text Key: 322986435
• Report Number: 9610595-2023-12976
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: 08/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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: BOSTON SCIENTIFIC HYDRATOME
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White